On September 11, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical-stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, reported its unaudited interim results for the six months ended June 30, 2026 which will also be made available on the Company’s website at View Source .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OPERATIONAL HIGHLIGHTS

The Company announced the following in the six months ended June 30, 2026:

· In-license of MTX240 (formerly OPB-171755) from Otsuka Pharmaceutical Co., Limited in February 2026 with a nominal upfront payment.

· Launch of a global Early Access Program for eRapa for FAP Patients through a strategic partnership with Tanner Pharma Group in March 2026.

· Approval from Health Canada to expand the Serenta trial into Canada in June 2026.

· Promotion of Fiona Sharp to Chief Financial Officer and Company Secretary, also joining the Board of Directors from January 2026.

Post period end:

· On July 1, 2026, the Company completed a fundraise raising gross proceeds of $3.5 million through a combination of a registered direct offering, warrant inducement and PIPE offering.

· As of the date of publication, 92 subjects, of a planned 168 subjects, have been enrolled in the Serenta trial.

FINANCIAL HIGHLIGHTS

· R&D costs increased to £2.92 million in 1H26 (1H25: £1.67 million) reflecting increased expenditure on the Serenta trial and manufacturing costs on the newly in-licensed MTX240 program.

· Administrative costs decreased to £1.74 million (1H25: £2.38 million) primarily as a result of foreign exchange movements.

· Net cash used in operating activities (after changes in working capital) in 1H26 was £4.61 million (1H25: £3.30 million).

· The Company’s cash balance at June 30, 2026 was £3.23 million.

Commenting, Stephen Stamp, CEO , said "We accomplished two main things in the first six months.

First, building on the advice we received from regulators, we accelerated enrolment into our registrational Phase 3 trial of eRapa in FAP. There are no approved therapeutics for FAP and passing the 50% enrolment in early August puts us significantly ahead of any competitive development programs.

Second, in-licensing MTX240 for GIST rounds out our GI cancer portfolio and, given its unique mechanism of action, has the potential to treat GIST patients irrespective of their KIT or PDGFR mutation. The Phase 1b/2a trial we are working to initiate is designed to establish a safe and effective dose as well as an efficacy signal before the end of 2027.

As always, financing remains a challenge for companies of our size."

CHIEF EXECUTIVE’S REVIEW

Our main focus in the first half of 2026 was on (1) expanding our registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis ("FAP") in Europe, and (2) initiating activities for the re-start of a Phase 1 trial of MTX240 in gastrointestinal stromal tumors ("GIST") which was in-licensed in early February 2026.

R&D update

In the first half of 2026 we progressed our Phase 3 trial of eRapa in FAP and added MTX240, a novel Phase 1 ready asset for the treatment of GIST. As of today, we have two active sponsored programs and two investigator initiated programs:

MTX230 – eRapa

eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035.

Familial Adenomatous Polyposis

FAP is characterized by a proliferation of polyps in the colon, duodenum and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the gastrointestinal tract remain the standard of care. If untreated, FAP almost always leads to colorectal cancer. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US and in Europe.

Following encouraging results from an open label Phase 2 study, a Type C meeting with the FDA and scientific advice from the EMA, we initiated a registrational Phase 3 trial (NCT06950385) of eRapa in June 2025. The trial, branded "Serenta" is a double-blind placebo-controlled design, recruiting 168 high risk subjects diagnosed with germline or phenotypic FAP. The primary clinical endpoint is first progression free survival event which will comprise composite endpoints including major surgery. As of the date of publication, 92 subjects have been recruited in the trial across 19 centers in the US and 10 centers in five European countries. Two centers in Canada are expected to begin enrolling in 4Q26.

Non-muscle Invasive Bladder Cancer ("NMIBC")

NMIBC refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guerin ("BCG") with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women.

The ongoing investigator initiated two-center, double-blind, placebo-controlled Phase 2 trial in NMIBC (NCT04375813) is fully enrolled at 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The study, which is supported by a $3.0 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health, is expected to read out in Q426.

MTX240 – molecular glue

We in-licensed global rights (excluding Japan) to MTX240 from Otsuka Pharmaceutical Co, Limited ("Otsuka") in early February 2026. Discovered by Otsuka and originally coded OPB-171755, MTX240 is a novel molecular glue we intend to develop for the treatment of GIST. Its unique mechanism of action brings together two intracellular proteins, PDE3A and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT or PDGFR signaling. GIST is mostly driven by activating mutations in the KIT receptor tyrosine kinase. Although tyrosine kinase inhibitors ("TKIs") such as imatinib, sunitinib, and regorafenib have significantly improved outcomes for GIST patients, resistance almost always develops through secondary KIT or PDGFR mutations or activation of alternative signaling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs. Molecular glue technology represents a novel approach that induces targeted protein interactions, offering a distinct mechanism of action to conventional kinase inhibitors for GIST and by triggering cell death through an alternative pathway MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors.

Gastrointestinal Stromal Tumors (GIST)

GIST is a rare gastrointestinal malignancy affecting approximately 3,000-4,000 patients annually in the US, with a significant unmet medical need for patients who develop TKI resistance. Approximately 10-15% of GIST patients are either primarily refractory, or develop secondary resistance to available TKIs whereupon options for these patients remain limited.

The global GIST market is valued at approximately $1.3 billion and is expected to grow at 6-10% annually through 2032, driven by rising incidence and emerging therapeutic options targeting treatment-resistant disease.

GIST qualifies for orphan drug designation in major regulatory jurisdictions, offering potential regulatory advantages and incentives to support drug development.

We are in the process of initiating activities for the re-start of a Phase 1 dose escalation and dose optimization trial, most likely an open label trail in GIST patients with no available therapeutic options. GMP clinical trial supplies are being developed and manufactured by Syngene International Limited. In the meantime, we are preparing regulatory submissions for a pre-IND meeting with the FDA.

MTD228 – Tolimidone

Tolimidone was originally discovered by Pfizer and was developed through Phase 2 for the treatment of gastric ulcers. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate-1, thereby amplifying the signaling cascade initiated by the binding of insulin to its receptor.

Type 1 Diabetes ("T1D")

Tolimidone’s potential utility in T1D has been demonstrated by several preclinical studies conducted by the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models. Tolimidone appeared to induce proliferation in beta cells isolated from human cadavers. In a meta analysis of 1,202 articles and 193 studies, the incidence of T1D was shown to be 15 per 100,000 with a prevalence of 9.5 per 10,000 of the population.

An ongoing Phase 2a investigator initiated trial at the University of Alberta Diabetes Institute (NCT06474598) is designed to establish the minimum effective dose of tolimidone in patients with T1D. The study enrolled the first patient in June 2025 and is expected to recruit 12 patients initially across three dose groups. The study will measure C-peptide levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number of hyperglycemic events.

1H26 FINANCIAL REVIEW

The unaudited results for the six months ended June 30, 2026 are discussed below:

Key performance indicators (KPIs):

1H 2026 1H 2025 Change

R&D costs £2.92m £1.67m 75%
R&D as % of operating costs 63% 41% n/a
Net cash inflow/(outflow) for the period (£5.31m) £2.37m n/m

Biodexa’ s KPIs focus on the key areas of operating results, R&D spend and cash management. These measures provide information on the core R&D operations. Additional financial and non-financial KPIs may be adopted in due course.

Revenues

Revenue for both periods was £Nil. The last of the Company’s R&D collaborations concluded in September 2023.

Research and Development

R&D costs for 1H26 and 1H25, analyzed by development project indication were as follows:

Six months ended June 30 2026 2025
£’000 £’000
eRapa
Familial Adenomatous Polyposis 1,420 251
Non-muscle Invasive Bladder Cancer 2 127
Total eRapa 1,422 378

MTX240
GIST 295 -
Total MTX240 295 -

Tolimidone
Type 1 Diabetes 49 270
Total tolimidone 49 270

MTX110 (Panobinostat)
Diffuse Midline Glioma - -
Recurrent Glioblastoma 155 14
Medulloblastoma - -
Total MTX110 (Panobinostat) 155 14

Other preclinical - 1

R&D overheads 995 1,002

Total R&D 2,916 1,665

MTX230 eRapa Familial Adenomatous Polyposis costs are shown above net of grant income. For the six months ended June 30, this is analyzed as follows:

For period to 30 June 2026 2025
£’000 £’000

Grant income (2,818 ) (2,107 )
Gross costs 4,238 2,358
Net charge to income statement 1,420 251

% costs allocated against CPRIT grant 66 % 89 %

R&D costs in 1H26 increased by £1.25 million, or 75%, to £2.92 million compared with £1.67 million in 1H25. R&D costs as a percentage of total operating costs increased to 63% from 41%. The increase was predominantly due to increased activity on the MTX230 Serenta clinical trial, which increased by £1.04 million, and manufacturing costs on the Company’s new MTX240 program of £0.30 million. The percentage of MTX230 (eRapa) costs offset against grant funding during the period was 66%, compared with 89% in 1H25. The Company anticipates that this percentage will be 67% over the life of the grant.

Administrative Costs

Administrative costs in 1H26 decreased by £0.64 million, or 27%, to £1.74 million from £2.38 million in 1H25. The decrease was driven primarily by foreign exchange movements, with a gain of £0.08 million recognized in 1H26 compared with a charge of £0.40 million in 1H25. Professional fees also decreased by £0.12 million in the period.

Finance Income and Expense

Finance income in 1H26 included gains in respect of an equity-settled derivative financial liability of £2.38 million (1H25: £0.15 million). The gains arose as a result of the fall in the Biodexa share price. In addition, the Company earned interest on cash deposits.

Finance expense in the period related to lease liabilities and discounted interest on deferred consideration.

Cash Flows

Cash outflows from operating activities in 1H26 were £4.61 million compared to £3.30 million in 1H25, driven by a net loss of £1.84 million (1H25: £3.81 million) and after negative working capital of £0.55 million (1H25: negative £0.04 million) and other negative non-cash items totaling £2.22 million (1H25: positive £0.24 million).

Net cash used in investing activities in 1H26 was £0.63 million (1H25: outflow of £0.34 million). This comprised £0.71 million of cash outflows relating to the purchase of the MTX240 license from Otsuka for total consideration of £0.37 million and the payment of deferred consideration on the eRapa license of £0.34 million (1H25: £0.37 million), offset by £0.09 million of interest received (1H25: £0.04 million).

Net cash used in financing activities in 1H26 was £0.07 million (1H25: inflow of £6.01 million), reflecting payments on lease liabilities.

Overall, cash decreased by £5.31 million in 1H26 compared with an increase of £2.37 million in 1H25. This resulted in a cash balance at June 30, 2026 of £3.23 million compared with £4.04 million at June 30, 2025 and £8.53 million at December 31, 2025.

Financing

On June 30, 2026, the Company entered into a securities purchase agreement utilizing its Registration Statement on Form F-3 to issue 82,809 ADSs and 200,143 pre-funded ADS warrants. In a concurrent Private Placement the Company agreed to issue 350,877 pre-funded ADS warrants. Each ADS was sold at an offering price of US$2.85, and each Pre-Funded Warrant was sold at an offering price of US$2.8499. In connection with the securities purchase agreement the Company agreed, upon receipt of Shareholder Approval, to issue 282,952 Series M Warrants and 701,754 Series N Warrants. The Series M and Series N Warrants have an exercise price of US$2.85 per ADS and have a term of five years from the date Shareholder Approval is obtained.

In addition, the Company entered into a warrant exercise inducement letter with a holder of Series L Warrants to purchase 609,756 ADSs at a reduced exercise price of US$2.85 per ADS. In consideration, the Company agreed, upon receipt of Shareholder Approval, to issue Series O Warrants to purchase an aggregate of 1,219,512 ADSs upon exercise of the existing warrants. The Series O Warrants have an exercise price of US$2.85 per ADS and a term of five years from the date Shareholder Approval is obtained.

The above transactions completed on July 1, 2026 and raised $3.5 million of gross proceeds.

Going concern

Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to June 30, 2026, the Group incurred a consolidated loss of £1.84 million (1H25: £3.81 million) and negative cash flows from operating activities of £4.61 million (1H25: £3.30 million). As of June 30, 2026, the Group had accumulated deficit of £157.60 million.

The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering the Company’s assets. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

The Directors believe there are adequate options and time available to secure additional financing for the Group and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group’s consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

As at June 30, 2026, the Group had cash and cash equivalents of £3.23 million. On July 1, 2026, the Company completed the financing transaction described above, raising gross proceeds of $3.5 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required during Q4 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Pursuant to its $35 million Equity Line of Credit ("ELOC") entered into in 2025, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price. There is no guarantee that the Company will be able to use the ELOC or raise from other financing to the extent necessary to finance the Company’s operations. As at 30 June 2026 $26.08 million remains undrawn from the ELOC.

In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Group would be successful.

The Directors have also considered the potential impact of Nasdaq’s proposed minimum market value requirement. Although implementation of the proposed rule has been stayed pending full Commission review, Biodexa’s current market capitalization is below the announced $5 million threshold. If implemented, or if the Company otherwise failed to maintain compliance with Nasdaq listing requirements, this could adversely affect the Company’s ability to raise funds, reduce investor appetite and limit the strategic value of the Company’s Nasdaq listing in connection with potential merger or reverse merger opportunities.

This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Group which are actionable before its cash resources run out, the Group will no longer be a going concern. In such circumstances, the Group would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis, assets would be stated at net realizable value, and liabilities would be accelerated to current liabilities.

(Press release, Biodexa Pharmaceuticals, SEP 11, 2026, View Source [SID1234670755])

On September 11, 2026 Johnson & Johnson (NYSE:JNJ) reported it will present new RYBREVANT (amivantamab-vmjw) and RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) data at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC), driving meaningful progress in care for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Presentations will include final overall survival results with RYBREVANT plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC selected for the Presidential Symposium, as well as new findings showing low rates of key treatment-related events with RYBREVANT FASPRO and prophylactic strategies in patients with common EGFR mutations, providing insights to help shape clinical practice and improve treatment experience.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Perspectives on key data at WCLC

"The evidence supporting RYBREVANT is resetting survival and treatment experience expectations for people living with EGFR-mutated non-small cell lung cancer, with outcomes that once seemed out of reach," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "The data at WCLC reinforce the clinical potential of RYBREVANT and its dual targeting of EGFR and MET as we continue to advance new approaches aimed at helping more patients live longer and achieve meaningful benefit from treatment."

Key data demonstrate the long-term impact and continued advancement of RYBREVANT and RYBREVANT FASPRO, including:

Final overall survival analysis from the Phase 3 PAPILLON study, selected for the Presidential Symposium, evaluating first-line RYBREVANT plus chemotherapy in NSCLC with EGFR exon 20 insertions (Late-breaking Abstract PL.03.03)
Longer follow-up from the Phase 2 COPERNICUS study evaluating RYBREVANT FASPRO plus LAZCLUZE (lazertinib) with prophylactic strategies in first-line EGFR-mutated NSCLC (Mini Oral Abstract MO12.09)
Updated findings from the Phase 2 PALOMA-2 study evaluating first-line RYBREVANT FASPRO plus LAZCLUZE in EGFR-mutated NSCLC (Late-breaking Poster Tour Abstract PT2.03.06)
Real-world evidence across the EGFR treatment journey, including the impact of resistance mechanisms on overall survival in first-line treatment (Poster Abstract P2.184)
A complete list of Johnson & Johnson-sponsored abstracts is available on JNJ.com.

About non-small cell lung cancer

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.1,2 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.3 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.4 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.1,2,5,6,7,8 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.9 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.10,11 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.12 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.13

About RYBREVANT FASPRO and RYBREVANT

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.

The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE in first-line advanced EGFR-mutated NSCLC.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)* 14 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines for NSCLC for complete information.†‡

The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.†‡

Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.

The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.

About LAZCLUZE

In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE (marketed as LECLAZA in South Korea). LAZCLUZE is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.

The legal manufacturer for LAZCLUZE is Janssen Biotech, Inc. and Yuhan Corporation.

INDICATIONS

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:

in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT15,16

CONTRAINDICATIONS

RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO

RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).

Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.

Infusion-Related Reactions with RYBREVANT

RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.

RYBREVANT as a Single Agent

In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

Interstitial Lung Disease/Pneumonitis

RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with LAZCLUZE

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.

RYBREVANT as a Single Agent

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE

RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.

Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.

Dermatologic Adverse Reactions

RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.

RYBREVANT with LAZCLUZE

In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.

RYBREVANT as a Single Agent

In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity

Hepatotoxicity

LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).

RYBREVANT with LAZCLUZE

In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.

Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.

Ocular Toxicity
RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.

RYBREVANT with LAZCLUZE

In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.

RYBREVANT as a Single Agent

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.

Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.

Embryo-Fetal Toxicity

Based on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.

ADVERSE REACTIONS

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).

Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

RYBREVANT with Carboplatin and Pemetrexed

In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

RYBREVANT as a Single Agent

In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

LAZCLUZE DRUG INTERACTIONS

Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

(Press release, Johnson & Johnson, SEP 11, 2026, View Source [SID1234670754])

On September 11, 2026 Handa Pharmaceuticals, Inc. ("Handa" or the "Company") (TSE:6620) reported that the U.S. Food and Drug Administration ("FDA") has granted final approval to OMCAZIO (cabozantinib) capsules, the laurylsulfate salt formulation of cabozantinib developed by the Company’s U.S. subsidiary, Handa Oncology, LLC. The action converts Handa’s prior tentative approval to final approval and authorizes OMCAZIO for commercialization in the United States.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Final approval from the FDA is a landmark milestone for Handa and reflects our patient-centered approach to pharmaceutical innovation," said Bill Liu, Chairman and CEO of Handa. "OMCAZIO is a differentiated cabozantinib option that can be taken with or without food, giving physicians and patients added flexibility in treatment."

Based on the approved prescribing information, OMCAZIO is indicated for the treatment of:¹

adult patients with advanced renal cell carcinoma (RCC);
adult patients with advanced RCC, as a first-line treatment in combination with nivolumab;
adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and
adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).

OMCAZIO is supplied in 34.5 mg, 23 mg, and 11.5 mg capsule strengths. OMCAZIO is not substitutable on a milligram-to-milligram basis with other cabozantinib products. The approved labeling includes the following recommendations for conversion between OMCAZIO and CABOMETYX:¹

CABOMETYX tablets dosage OMCAZIO capsules dosage
60 mg once daily 34.5 mg once daily
40 mg once daily 23 mg once daily
20 mg once daily 11.5 mg once daily
Cabozantinib is one of the commonly used oral targeted therapies in oncology. According to Exelixis, Inc., U.S. net product revenues for CABOMETYX were approximately $2.11 billion in 2025, an increase of approximately 17% over 2024.²

Handa expects to provide additional information regarding U.S. commercial availability of OMCAZIO in a subsequent announcement.

Important Safety Information

Boxed Warning: RISK OF SERIOUS ADVERSE REACTIONS OR REDUCED EFFECTIVENESS DUE TO MEDICATION ERRORS

OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Inappropriate substitution or incorrect conversion of OMCAZIO capsules for another cabozantinib product can increase the risk of serious adverse reactions. Confirm that the intended cabozantinib product at the intended dosage and strength is being prescribed and dispensed.

WARNINGS AND PRECAUTIONS

Risk of Serious Adverse Reactions or Reduced Effectiveness Due to Medication Errors: Cabozantinib is available in multiple dosage forms and strengths. OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Confirm that the intended cabozantinib product is being prescribed and dispensed.

Hemorrhage: Do not administer OMCAZIO if recent history of hemorrhage.

Perforations and Fistulas: Monitor for symptoms. Discontinue OMCAZIO for Grade 4 events.

Thromboembolic Events: Discontinue OMCAZIO for myocardial infarction or serious venous or arterial thromboembolic events.

Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Interrupt OMCAZIO for hypertension not adequately controlled with anti-hypertensive therapy. Discontinue OMCAZIO for hypertensive crisis or severe hypertension that cannot be controlled.

Cardiac Failure: Monitor for signs and symptoms of cardiac failure throughout treatment.

Diarrhea: May be severe. Interrupt OMCAZIO until diarrhea resolves or improve to ≤Grade 1, then resume at reduced dose. Recommend standard antidiarrheal treatments.

Palmar-Plantar Erythrodysesthesia (PPE): Interrupt OMCAZIO treatment until PPE resolves or improves to Grade 1.

Hepatotoxicity: When used with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than with OMCAZIO alone. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider withholding OMCAZIO and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity.

Adrenal Insufficiency: When used in combination with nivolumab, primary or secondary adrenal insufficiency may occur. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold OMCAZIO and/or nivolumab depending on severity.

Proteinuria: Monitor urine protein. Interrupt OMCAZIO until proteinuria resolves to ≤Grade 1, resume OMCAZIO at a reduced dose. Discontinue for nephrotic syndrome.

Osteonecrosis of the jaw (ONJ): Withhold OMCAZIO for at least 3 weeks prior to invasive dental procedures and for development of ONJ.

Impaired Wound Healing: Withhold OMCAZIO for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of OMCAZIO after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue OMCAZIO.

Thyroid Dysfunction: Monitor thyroid function before and during treatment with OMCAZIO.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

The most common adverse reactions (≥20%) include:

OMCAZIO as a single agent – diarrhea, fatigue, palmar‑plantar erythrodysesthesia (PPE), decreased appetite, hypertension, nausea, vomiting, decreased weight, and constipation.
OMCAZIO in combination with nivolumab – diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.
Drug Interactions

Strong CYP3A inhibitors: Reduce the OMCAZIO dosage if coadministration cannot be avoided.

Strong or moderate CYP3A inducers: Increase the OMCAZIO dosage if coadministration cannot be avoided.

Contraindication

None.

Use in Specific Populations

Lactation: Advise not to breastfeed.

Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing OMCAZIO if abnormalities occur.

About OMCAZIO

OMCAZIO (cabozantinib) capsules are the laurylsulfate salt formulation of cabozantinib, a kinase inhibitor, developed under the 505(b)(2) regulatory pathway. OMCAZIO may be taken with or without food and is available in lower milligram-strength capsules that correspond to the approved CABOMETYX doses in accordance with the FDA-approved dose-conversion recommendations.

(Press release, Handa Oncology, SEP 11, 2026, View Source [SID1234670753])

On September 11, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE natural killer (NK) cell engager platform, reported it will host a live company presentation on the development of the TriKE platform for cancer treatment, September 11, 2026, at 2:00 p.m. Eastern Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webinar will feature Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma, and Dr. Jeffrey Miller, MD1, Consulting Senior Medical Director, who will discuss clinical progress in blood cancers and solid tumors, insights from increasing dose levels, the platform’s competitive positioning, and key milestones ahead.

Webinar Information:
Title: The TriKE Platform, Clinical Progress, and the Case for NK Cell Immunotherapy
Date: Friday, September 11, 2026
Time: 2:00 p.m. Eastern Time
Webcast: Please click here to register.

A replay of the webcast will be made available at gtbiopharma.com following the event.

(Press release, GT Biopharma, SEP 11, 2026, View Source [SID1234670752])

On September 11, 2026 Exelixis reported that the U.S. Food and Drug Administration (FDA) notified about extending the review period for Exelixis’ new drug application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer by three months. In response to an FDA information request, Exelixis had submitted updated safety and efficacy data, which the FDA has deemed a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, Exelixis, SEP 11, 2026, View Source [SID1234670750])