Genmab Presents the Safety and Tolerability of Rinatabart Sesutecan (Rina-S®) in Combination with Bevacizumab in Advanced Ovarian Cancer

On April 13, 2026 Genmab A/S (Nasdaq: GMAB) reported new data demonstrating that rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in San Juan, Puerto Rico.

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"Advanced ovarian cancer is a complex and difficult-to-treat disease, and the ability for investigational therapies such as Rina-S to be safely combined with bevacizumab can provide clinicians with more options to help improve disease control and manage resistance," said Cara Mathews, M.D., study investigator and Associate Professor, Obstetrics and Gynecology at the Women and Infants Hospital, Brown University. "Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care therapy such as bevacizumab without significantly increasing the risk of additional side effects."

As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S (120 mg/m2) plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events (AEs). The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common (≥25%) treatment-emergent AEs (TEAEs) included nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients (15.0%), and TEAEs leading to Rina-S dose reductions occurred in 11 patients (27.5%). Rina-S and bevacizumab discontinuation occurred in two patients (5%). No fatal TEAEs were reported.

"Today’s safety results from RAINFOL-01 add to the growing body of clinical evidence supporting further development of Rina-S in advanced ovarian cancer, including its potential to be used in a combination regimen," said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. "Rina-S has the potential to meaningfully expand treatment possibilities for patients with certain gynecologic cancers, and we look forward to further investigating additional opportunities, alone and with other therapies, as Rina-S advances through late-stage clinical development."

Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial (NCT06619236) in patients with platinum-resistant ovarian cancer (PROC), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, and the Phase 3 RAINFOL-04 trial (NCT07225270) in patients with recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy. Rina-S is also being evaluated in the Phase 2 RAINFOL-05 study (NCT07288177) in patients with non-small cell lung cancer (NSCLC).

About the RAINFOL-01 Trial
RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of Rina-S Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part D combination therapy cohorts.

About Ovarian Cancer
Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Standard of care for PROC typically involves single-agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel) and mirvetuximab for FRα-positive (≥75% positive tumor cells) patients.iv,v Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.vi Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vii,viii

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial and other cancers with unmet need.

The safety and efficacy of Rina-S has not been established. Please visit View Source for more information.

(Press release, Genmab, APR 13, 2026, View Source [SID1234664317])

Sirtex Medical’s DOORwaY90 Study Demonstrates 100% Local Tumor Control with SIR-Spheres®, Setting a New Benchmark in Y-90 for HCC

On April 13, 2026 Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology and embolization solutions, reported landmark 12-month results from the DOORwaY90 study, the first pivotal, prospective, multicenter U.S. trial of Y-90 selective internal radiation therapy (SIRT) using partition dosimetry in patients with unresectable hepatocellular carcinoma (HCC).

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The DOORwaY90 study met its prespecified co-primary endpoints, demonstrating a 90% complete response (CR) rate and a best overall response rate (ORR) of 99%, as assessed by blinded independent central review. All evaluable patients responded to treatment, resulting in 100% local tumor control—one of the highest reported response outcomes in Y-90 therapy. Responses were durable, with 75% lasting beyond six months and a median duration of 295 days, reinforcing the potential of SIR-Spheres Y-90 resin microspheres to deliver sustained tumor responses while preserving liver function.

Importantly, over 95% of patients maintained stable liver function at 12 months, underscoring the ability of personalized dosimetry to achieve aggressive tumor response without compromising hepatic reserve.

These results were presented as a late-breaking oral presentation at the Society of Interventional Radiology (SIR) Annual Meeting in Toronto, Canada.

"These 12-month results demonstrate the consistency of response achievable with personalized dosimetry," said Dr. Armeen Mahvash, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 study. "The high complete response rates, durability and preservation of liver function observed in this study give physicians increased confidence in using radioembolization as a definitive, liver-directed treatment option."

"These results raise the bar for what physicians should expect from Y-90 therapy," said Matt Schmidt, CEO of Sirtex Medical. "With the overall response rate of 99% and 100% tumor control, DOORwaY90 demonstrates that personalized dosimetry with SIR-Spheres can deliver outcomes that challenge conventional approaches and expand what’s possible in liver-directed therapy for patients with unresectable HCC."

SIR-Spheres Y-90 resin microspheres are the only radioembolization therapy approved by the FDA for the treatment of both metastatic colorectal cancer (mCRC) of the liver and unresectable HCC in the U.S.

For more information about SIR-Spheres and guidance on incorporating personalized dosimetry into clinical practice, please contact Sirtex at [email protected].

About SIR-Spheres
SIR-Spheres Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Common side effects include abdominal pain, nausea and constipation. Consult www.sirtex.com/sir-spheres/risks_adverse-events for a complete listing of side effects, warnings and precautions.

(Press release, Sirtex Medical, APR 13, 2026, View Source [SID1234664334])

Entry into a Material Definitive Agreement

On April 12, 2026, ImageneBio, Inc., a Delaware corporation (the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain institutional and accredited investors (the "Investors"), pursuant to which the Company agreed to sell and issue pre-funded warrants to purchase shares of the Company’s voting common stock, par value $0.001 ("Common Stock" and the shares subject to the pre-funded warrants, the "Warrant Shares"), in a private placement transaction (the "Private Placement").

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The closing of the Private Placement is anticipated to occur on or about April 14, 2026 (the "Closing"), subject to customary closing conditions. At the Closing, the Company has agreed to issue and sell pre-funded warrants to purchase up to 5,770,335 Warrant Shares at a purchase price of $5.199 per Warrant Share to the Investors for gross proceeds to the Company of approximately $30 million pursuant to the Purchase Agreement.

The pre-funded warrant will have an exercise price of $0.001 per Warrant Share, subject to customary adjustments, and will be exercisable at any time after original issuance and will not expire until exercised in full. The pre-funded warrant will also be exercisable on a net exercise "cashless" basis. The pre-funded warrant may not be exercised if the aggregate number of shares of Common Stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation, not to exceed 19.99%.

The Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Purchase Agreement is included with this filing only to provide investors with information regarding the terms of the transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures.

Registration Rights Agreement

In connection with the Private Placement, the Company has agreed to enter into a Registration Rights Agreement (the "Registration Rights Agreement") with the Investors at the Closing, pursuant to which the Company will agree to prepare and file, within three business days following August 1, 2026, subject to certain allowable delays, a registration statement with the U.S. Securities and Exchange Commission (the "SEC") to register for resale the Warrant Shares issuable upon the exercise of the pre-funded warrants that were issued and sold under the Purchase Agreement, and generally to cause the applicable registration statement to promptly become effective. Certain cash penalties will apply to the Company in the event of registration failures, as described in the Registration Rights Agreement.

The foregoing summaries of the Purchase Agreement, the pre-funded warrant and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the complete text of the Purchase Agreement, the form of pre-funded warrant and the Registration Rights Agreement, which are filed with this report as Exhibits 10.1, 4.1 and 4.2, respectively.

(Filing, ImaGene, APR 12, 2026, View Source [SID1234664319])

GSK presents positive data for B7-H4-targeted ADC in gynaecological cancers

On April 12, 2026 GSK plc (LSE/NYSE: GSK) reported positive findings from its global phase I BEHOLD-1 clinical trial for mocertatug rezetecan (or Mo-Rez for short), a novel antibody-drug conjugate (ADC) targeting the B7-H4 antigen. At the highest doses evaluated, Mo-Rez monotherapy achieved confirmed objective response rates (cORR) of 62% (5.8 mg/kg n=21/34; 95% CI: 44, 78) in platinum-resistant ovarian cancer (PROC) and 67% (4.8 mg/kg n=8/12; 95% CI: 35, 90) in recurrent or advanced endometrial cancer (EC).1 These data will be presented for the first time in a late-breaking oral session at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in San Juan, Puerto Rico.

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Currently, there are limited treatment options with modest response rates for patients with PROC and advanced EC. B7-H4 is an immune checkpoint that is widely expressed in ovarian and endometrial cancers and is low in normal tissues, providing potential for a differentiated precision-therapy. The response to Mo-Rez observed across a range of B7-H4 expression levels reinforces its broad potential in gynaecologic cancers and further validates the relevance of targeting B7-H4.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Treatment of gynaecological cancers remains a major challenge, with a pressing need for new therapies that offer improved response rates. With Mo-Rez, we now have compelling evidence of a promising clinical profile, with response rates that support accelerating development into five pivotal global phase III trials later this year across ovarian and endometrial cancers, including earlier line settings."

Ana Oaknin, Study Investigator for BEHOLD-1, Medical Oncology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain said: "In the early phase BEHOLD-1 study, we saw meaningful antitumour activity for this patient dataset, with response rates higher than typically seen in ADCs in development, and a manageable safety profile. For patients with platinum-resistant ovarian cancer and recurrent endometrial cancer, these findings are particularly encouraging."

At the highest doses evaluated in BEHOLD-1, few patients needed to stop treatment because of a treatment-related adverse events (TRAE) (0% in PROC and 4% in EC). The most common TRAE was nausea (82% in PROC; 75% in EC). Grade ≥3 TRAEs occurred in 64% and 54% patients in PROC and EC, respectively, and were predominantly haematologic, as expected for treatments in this class. Overall rates of interstitial lung disease or pneumonitis were low (3%; 5 out of 178 patients) and all cases were mild to moderate (grade 1-2). The interim analysis showed the median duration of response had not yet been reached. Based on the findings from this study, the recommended dose for the first of the phase III trials, BEHOLD-Ovarian01 and BEHOLD-Endometrial01, is 5.8 mg/kg.

About the BEHOLD clinical trial programme
The BEHOLD clinical programme is GSK’s global development plan that includes the BEHOLD-1 (NCT06431594) monotherapy study and the ongoing BEHOLD-2 (NCT06796907) combination study. Mo-Rez will advance to five pivotal global phase III trials in 2026, starting with PROC (BEHOLD-Ovarian01 / NCT07286266) and 2L EC (BEHOLD-Endometrial01 / NCT07286331). Additional phase III studies will evaluate Mo‑Rez in platinum‑sensitive ovarian cancer (BEHOLD-Ovarian02) and in first‑line maintenance settings for ovarian cancer without homologous recombination deficiency (BEHOLD-Ovarian03) and mismatch‑repair–proficient endometrial cancer (BEHOLD-Endometrial02).

About BEHOLD-1
The BEHOLD-1 clinical trial is a two-part, open-label, phase I study evaluating the safety, tolerability and efficacy of Mo-Rez injection in patients with PROC or advanced/recurrent EC. Phase Ia assessed up to four Mo-Rez dose levels in patients with advanced solid tumours, with intravenous administration every three weeks until progression or toxicity. In the phase Ib dose expansion, patients with PROC or EC (1–3 prior lines of therapy) were randomised to three or two Mo-Rez dose levels, respectively.

At data cut-off, a total of 224 patients were enrolled in BEHOLD-1; n=44 in phase 1a (n=21 PROC, n=23 mix of other solid tumours) and n=180 in phase Ib (n=131 PROC, n=49 EC). Primary endpoints included: incidence of dose-limiting toxicity in phase Ia and confirmed ORR (cORR) by investigator per RECIST 1.1 in phase Ib. At the highest dose evaluated in phase Ib, the most common adverse events in PROC were nausea (86%), neutropenia/neutrophil count decreased (73%), anaemia (52%), fatigue (52%) and alopecia (52%). In EC, the most common adverse events were nausea (79%), neutropenia/neutrophil count decreased (58%), anaemia (54%), vomiting (46%) and fatigue (42%). Treatment related adverse events led to dose interruptions in 39% of patients with PROC and 21% of those with EC, and to dose reductions in 39% in PROC and 17% in EC, at the highest dose. The trial is ongoing and currently in the dose expansion phase.

About mocertatug rezetecan
Mo-Rez is a novel investigational B7-H4-targeted antibody-drug conjugate designed to optimise efficacy and tolerability. It is composed of a fully human anti-B7-H4 monoclonal antibody covalently linked to a topoisomerase inhibitor payload and has a drug-to-antibody ratio (DAR) of 6. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Mo-Rez globally.

About ovarian cancer and endometrial cancer
Endometrial cancer affects 1.6 million people globally, with 417,000 new cases each year and 15% to 20% of patients presenting in later stages of the disease.2,3 Ovarian cancer affects 843,000 people with 240,000 new cases annually.4 70% of these patients present with advanced disease.5 Recurrence is common in advanced cases of disease, up to 67% in endometrial cancer and 70% in ovarian cancer, and survival usually declines after recurrence.

(Press release, GlaxoSmithKline, APR 12, 2026, View Source [SID1234664307])

AbbVie Showcases Late‑Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum‑Sensitive Ovarian Cancer (PSOC) at SGO 2026

On April 12, 2026 AbbVie (NYSE: ABBV) reported that late-breaking results from the Phase 2 IMGN853-0420 trial will be presented in an oral session at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting (San Juan, Puerto Rico; April 10-13, 2026). The study evaluated the potential efficacy and safety of mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate (ADC), in combination with carboplatin followed by maintenance of mirvetuximab soravtansine-gynx monotherapy, in patients with folate receptor alpha (FRα)-expressing, recurrent platinum‑sensitive ovarian cancer (PSOC).

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The multicenter, open-label study enrolled 125 patients with FRα‑positive, measurable disease who had received one prior platinum‑based chemotherapy regimen. Participants received mirvetuximab soravtansine-gynx plus carboplatin every three weeks for six to eight cycles, followed by single-agent mirvetuximab soravtansine-gynx as a continuation therapy. Nearly half of patients had prior exposure to a polymerase inhibitor (PARPi), a patient population who may experience reduced responses to subsequent platinum-based chemotherapy.1

The primary endpoint of the study was a confirmed objective response rate (ORR) in the ≥50% FRα subgroup after six cycles of combination therapy.2 Key secondary endpoint was ORR after six cycles in the overall population (FRα ≥25%) and additional secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS).

"Despite being considered chemotherapy-responsive, platinum-sensitive ovarian cancer (PSOC) remains challenging to treat. With each recurrence, responses to standard platinum-based chemotherapy often diminish and patients may experience cumulative toxicities,"3 said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These results are encouraging and further support the potential of mirvetuximab soravtansine-gynx in PSOC as a novel treatment regimen."

Key highlights from the late-breaking oral presentation include:

Response rates across combination regimen: By the end of the induction phase, confirmed ORR was 62.7% (95% CI, 52.6–72.1) in the FRα ≥50% subgroup and 62.4% (95% CI, 53.3–70.9) in the overall population. 81% of patients (101/125) showed no disease progression and continued treatment with single-agent mirvetuximab soravtansine.2 Median DoR was 11.2 months across the overall population.2
Additional responses with continuation monotherapy: Among patients who were on the combination and transitioned to mirvetuximab soravtansine-gynx monotherapy, ORR was 68% (59.1–76.1) across the overall population.2
Responses in patients with prior exposure to polymerase inhibitor (PARPi): In nearly half of patients (49%) in the overall population (FRα ≥25%) who had prior PARPi exposure, ORR was 63.9% (50.6–75.8).2
Safety data: The safety profile of mirvetuximab soravtansine-gynx was consistent with findings from previous studies. The most common treatment-related adverse events (TRAEs) with mirvetuximab soravtansine-gynx plus carboplatin followed by a continuation of mirvetuximab-soravtansine-gynx alone were low‑grade ocular events, including corneal changes that were reversible in over 90% of patients.2 The most common grade ≥3 TRAEs (>5%) were neutropenia (15%), blurred vision (10%), thrombocytopenia (10%), cataract (6%), dry eye (5%), diarrhea (5%) and peripheral sensory neuropathy (5%).2
"The combination of mirvetuximab soravtansine-gynx and carboplatin delivered strong responses in this Phase 2 study and many patients continued to experience responses during the monotherapy treatment phase," said Gottfried E. Konecny, M.D., Professor of Medicine, David Geffen School of Medicine at UCLA, and primary investigator. "These findings support further investigation of a novel treatment approach that integrates antibody drug conjugates with standard chemotherapy in patients with folate receptor alpha (FRα)-expressing recurrent platinum‑sensitive ovarian cancer and in patients previously treated with PARP inhibitors who often face resistance and remain in need of additional options."

The data is being presented during the Rapid-Fire Oral III: Translational and ADC session on Sunday, April 12 at 12:32 PM ET. More information about the 2026 SGO Annual Meeting and abstracts being presented are available here.

Further information on AbbVie clinical trials is also available at View Source

Use of mirvetuximab soravtansine-gynx plus carboplatin followed by mirvetuximab soravtansine-gynx continuation in FRα-expressing recurrent PSOC is not approved in the U.S. or in the E.U. or in any other territory. The safety and efficacy of mirvetuximab soravtansine-gynx for use as a combination therapy in PSOC have not been established.

About the IMGN853-0420 Trial
IMGN853‑0420 (NCT05456685) is a multicenter, open‑label, single-arm Phase 2 study evaluating the efficacy and safety of carboplatin plus mirvetuximab soravtansine-gynx followed by mirvetuximab soravtansine-gynx continuation in folate receptor‑alpha (FRα) positive (≥25% tumor cells with ≥2+ membrane intensity), recurrent platinum-sensitive high‑grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following one prior line of platinum‑based chemotherapy. After completing six cycles of mirvetuximab soravtansine-gynx plus carboplatin, participants without progressive disease continue on single‑agent mirvetuximab soravtansine-gynx. Eligibility requires confirmed FRα positivity using the Ventana FOLR1 Assay, ensuring enrollment of participants most likely to benefit from this FRα‑targeted ADC approach.

About ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE is currently indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. It is being investigated in patients with platinum-sensitive ovarian cancer.

ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION

What is ELAHERE?

ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:

have not responded to or are no longer responding to treatment with platinum-based chemotherapy and
have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.
It is not known if ELAHERE is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ELAHERE?

ELAHERE can cause serious side effects, including:

Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.

Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.
Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.
Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.
What should I tell my healthcare provider before receiving ELAHERE?

Tell your healthcare provider about all of your medical conditions, including if you:

have vision or eye problems.
have numbness or tingling in your hands or feet.
have liver problems.
are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.
Patients who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.
You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.
are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.

What are the possible side effects of ELAHERE?

ELAHERE can cause serious side effects, including:

Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.
Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness.
The most common side effects and abnormal labs of ELAHERE include:

increased liver enzymes in the blood
feeling tired
blurred vision
nausea
diarrhea
stomach-area (abdominal) pain
changes in the cornea (part of the eye)
peripheral neuropathy
muscle, bone, or joint pain
decreased red or white blood cell counts

decreased platelets
decreased magnesium level in the blood
dry eye
constipation
vomiting
decreased albumin level in the blood
decreased appetite
Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.

These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

(Press release, AbbVie, APR 12, 2026, View Source [SID1234664309])