On July 24, 2025 GSK plc (LSE/NYSE: GSK) reported the approval of Blenrep in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide (Press release, GlaxoSmithKline, JUL 24, 2025, View Source [SID1234654502]).

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The approval is based on superior efficacy results demonstrated by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful progression-free survival (PFS) for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.2,3

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s approval of Blenrep combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU. Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings."

More than 50,000 cases of multiple myeloma are diagnosed in Europe each year, accounting for more than a quarter of global incidence.5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients with a differentiated mechanism of action to potentially help slow disease progression and extend survival.1 Blenrep combinations can be administered to a range of patient types across oncology treatment settings, enabling broad accessibility of an anti-BCMA therapy.

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said: "With the approval of Blenrep combinations in the EU, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival. The robust efficacy supported by the DREAMM-7 and DREAMM-8 trials, together with manageable outpatient administration in academic and community settings, positions Blenrep combinations as a fundamentally differentiated treatment approach for multiple myeloma patients starting from first relapse."

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.2,3 In DREAMM-7, the Blenrep combination (n=243) nearly tripled median PFS versus the daratumumab-based comparator (n=251) (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001).2 DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the Blenrep combination versus the daratumumab-based comparator (HR: 0.58; 95% CI: 0.43-0.79; p=0.00023). The median OS was not reached in either arm of the study. The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm.4 In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5) at the time of primary analysis.3

Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.2,3

DREAMM-7 and DREAMM-8 showed that eye-related side effects associated with Blenrep can be managed and reversed with appropriate dose modifications and follow-up. This allowed patients to maintain benefit and resulted in low rates of discontinuation due to eye-related side effects (≤9%) in both trials.2,3 The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in DREAMM-8.2,3

Blenrep combinations are also approved in relapsed or refractory multiple myeloma in the UK6 and Japan7 as well as other markets, including Canada and Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the US8 and China9 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.10,11 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.5 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.1 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.12,13

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
In the EU, Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
Refer to the Blenrep EMA Reference Information14 which will soon be available for a full list of adverse events and the complete important safety information in the EU.

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

PFS results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.2,4

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.3 Updated PFS results were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2025.

On July 24, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX (cabozantinib) for the treatment of adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues (Press release, Exelixis, JUL 24, 2025, View Source [SID1234654501]). This approval follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland.

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"The availability of CABOMETYX in the European Union for patients with previously treated advanced neuroendocrine tumors is a significant milestone as there have been limited treatment advancements in the past decade, including very few options shown to improve outcomes across a heterogenous population," said Amy Peterson, M.D., Executive Vice President, Product Development and Medical Affairs, and Chief Medical Officer, Exelixis. "This approval builds on the global CABOMETYX franchise and extends its benefit to even more patients in need of new treatment options. We are proud to partner with Ipsen in our shared commitment to improving the standard of care for people living with advanced, difficult-to-treat cancers."

The EC approval is based on results from the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. CABINET was the basis for the U.S. Food and Drug Administration approval of CABOMETYX in March 2025 for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET.

About CABINET (Alliance A021602)
CABINET (Randomized, Double-Blinded, Phase III Study of CABozantinib versus Placebo In Patients with Advanced NEuroendocrine Tumors After Progression on Prior Therapy) is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded National Clinical Trials Network, as part of Exelixis’ collaboration through a Cooperative Research and Development Agreement with the NCI’s Cancer Therapy Evaluation Program.

CABINET is a multicenter, randomized, double-blinded, placebo-controlled phase 3 pivotal trial that enrolled a total of 298 patients in two separate cohorts (pNET and epNET) in the U.S. at the time of the final analysis. Patients were randomized 2:1 to cabozantinib (60 mg) or placebo; each cohort was randomized separately and had its own statistical analysis plan. The trial was stopped early after an interim analysis showed superior efficacy associated with cabozantinib as compared to placebo in each of the two cohorts. Patients with epNET had primary tumors arising in the gastrointestinal (GI) tract, lung, unknown primary sites and other organs. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression or intolerance after at least one U.S. FDA-approved line of prior systemic therapy other than somatostatin analogs. The primary endpoint in each cohort was PFS per RECIST 1.1 by blinded independent central review. Secondary endpoints included overall survival, objective response rate and safety. More information about this trial is available at ClinicalTrials.gov.

About NET
NET are cancers that begin in the specialized cells of the body’s neuroendocrine system.1 These cells have traits of both hormone-producing endocrine cells and nerve cells.1 It is estimated that 161,000 to 192,000 people in the U.S. are living with unresectable, locally advanced or metastatic NET.2 The number of people diagnosed with NET has been increasing in recent decades.3 Functional NET release peptide hormones that can cause debilitating symptoms, like diarrhea, hypertension and flushing, while symptoms of non-functional NET are related primarily to tumor growth.4,5,6,7,8 Most NET take years to develop and grow slowly, but eventually all patients with advanced or metastatic NET will develop refractory and progressing disease.9,10

NET can start in the pancreas (pNET), where they tend to be more aggressive, with a five-year survival rate of only 23% for advanced disease.1,11 NET can also develop in any part of the body, but most commonly start in the GI tract or in the lungs, where they have historically been referred to as carcinoid tumors and are more recently called epNET.1 The five-year survival rates for advanced GI and lung NET tumors are 68% and 55%, respectively.12,13 For advanced NET patients, treatment options include somatostatin analogs, chemotherapy, molecular targeted therapy and peptide-receptor radionuclide therapy.14

About CABOMETYX (cabozantinib)
In the U.S., CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible; for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET. CABOMETYX tablets have also received regulatory approvals in over 65 countries outside the U.S. and Japan, including the EU. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: CABOMETYX can cause severe and fatal hemorrhages. The incidence of Grade 3-5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3-4 hemorrhage and before surgery. Do not administer to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, and gastrointestinal (GI) perforations, including fatal cases, each occurred in 1% of CABOMETYX patients. Monitor for signs and symptoms, and discontinue CABOMETYX in patients with Grade 4 fistulas or GI perforation.

Thrombotic Events: CABOMETYX can cause arterial or venous thromboembolic event. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events have occurred. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. In CABINET (n=195), hypertension occurred in 65% (26% Grade 3) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with antihypertensive therapy or for hypertensive crisis.

Diarrhea: CABOMETYX can cause diarrhea and it occurred in 62% (10% Grade 3) of treated patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to ≤ Grade 1; resume at a reduced dose.

Palmar-Plantar Erythrodysesthesia (PPE): CABOMETYX can cause PPE and it occurred in 45% of treated patients (13% Grade 3). Withhold CABOMETYX until PPE resolves or decreases to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab in RCC can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Monitor liver enzymes before initiation of treatment and periodically. Consider more frequent monitoring as compared to when the drugs are administered as single agents. Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity.

Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria; resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): CABOMETYX can cause ONJ and it occurred in <1% of treated patients. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution; resume at a reduced dose.

Impaired Wound Healing: CABOMETYX can cause impaired wound healing. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): CABOMETYX can cause RPLS. Perform evaluation for RPLS and diagnose by characteristic finding on MRI any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Thyroid Dysfunction: CABOMETYX can cause thyroid dysfunction, primarily hypothyroidism, and it occurred in 19% of treated patients (0.4% Grade 3). Assess for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitor for signs and symptoms during treatment.

Hypocalcemia: CABOMETYX can cause hypocalcemia, with the highest incidence in DTC patients. Based on the safety population, hypocalcemia occurred in 13% of CABOMETYX patients (2% Grade 3 and 1% Grade 4).

Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume CABOMETYX at a reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.

ADVERSE REACTIONS

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

CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, and constipation.

CABOMETYX 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 CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong or Moderate CYP3A4 Inducers: If coadministration with strong or moderate CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Pediatric Use: Physeal widening has been observed in children with open growth plates when treated with CABOMETYX. Physeal and longitudinal growth monitoring is recommended in children (12 years and older) with open growth plates. Consider interrupting or discontinuing CABOMETYX if abnormalities occur. The safety and effectiveness of CABOMETYX in pediatric patients less than 12 years of age have not been established.

On July 24, 2025 Eli Lilly and Company (NYSE: LLY) and Verve Therapeutics, Inc. (NASDAQ: VERV) reported that the tender offer to purchase all of the issued and outstanding shares ("Shares") of Verve’s common stock in exchange for (i) $10.50 per Share, net to the stockholder in cash, without interest and less any applicable tax withholding, plus (ii) one non-tradable contingent value right ("CVR") per Share, which represents the contractual right to receive a contingent payment of up to $3.00 per CVR, net to the stockholder in cash, without interest and less any applicable tax withholding, upon the achievement of a certain specified milestone (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern time, on July 23, 2025 and was not extended (such date and time, the "Expiration Time") (Press release, Eli Lilly, JUL 24, 2025, View Source [SID1234654500]).

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Computershare Trust Company, N.A., the depositary and paying agent for the Offer, has advised Lilly that, as of the Expiration Time, 49,882,464 Shares were validly tendered and not validly withdrawn in the Offer, representing approximately 55.7% of the issued and outstanding Shares as of the Expiration Time. Accordingly, all conditions to the Offer have been satisfied. Lilly and Ridgeway Acquisition Corporation, an indirect wholly owned subsidiary of Lilly, have accepted for payment, and will promptly pay for, all shares validly tendered and not validly withdrawn in the Offer.

The parties expect to consummate the acquisition on July 25, 2025, in accordance with, and subject to the terms of, the definitive agreement for the proposed acquisition.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Verve, Centerview Partners LLC and Guggenheim Securities, LLC are acting as financial advisors and Paul, Weiss, Rifkind, Wharton & Garrison LLP, is acting as legal counsel.

On July 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the second quarter of fiscal year 2025 (Press release, Chugai, JUL 24, 2025, View Source [SID1234654499]).

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Chugai reported increased revenue and operating profit year-on-year for the second quarter (Core-basis).

Regarding revenue, domestic sales increased by 2.8%. In the oncology field, sales decreased by 1.9%. While new products Phesgo performed well and Lunsumio steadily penetrated the market, this was offset by the decline in Perjeta and Herceptin along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients. Additionally, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars. In the specialty field, sales increased by 8.4%, driven by significant growth of the mainstay product Vabysmo and successful market penetration of the new product PiaSky. Overseas sales increased by 7.3%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.4%, despite the increase in royalty income related to Hemlibra, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 1.3 percentage points year-on-year to 34.3%, mainly due to changes in the product mix. Research and development expenses increased by 2.7% due to investments into drug discovery and early development, and increase associated with the progress of development projects, while selling, general and administrative expenses decreased by 2.6% due to efficient management of various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥272.0 billion (+3.5%).

Chugai made good progress in both early and late-stage development activities.

In early-stage development of in-house projects that will drive mid to long-term growth, GYM329 (for obesity) and Hemlibra (for von Willebrand disease) have initiated Phase II and Phase III clinical trials, respectively. Additionally, AUBE00 (for solid tumors), the second clinical-stage project following LUNA18 in our mid-size molecule pipeline, has initiated Phase I clinical trials. In late-stage development, Alecensa has been filed for approval for additional tumor agnostic indication in ALK fusion / rearrangement gene-positive solid tumors, including pediatric patients. In-house projects out-licensed to third parties excluding Roche also progressed steadily, with AVMAPKI, out-licensed to Verastem Oncology, receiving approval from the U.S. Food and Drug Administration (FDA) for use in combination with FAKZYNJA for KRAS-mutated recurrent low-grade serous ovarian cancer, under the accelerated approval pathway* based on overall response rate and duration of response.

Chugai has made the management decision to discontinue our development of five projects from early-stage in-house clinical development pipeline; LUNA18, SAIL66, SOF10, STA551, and AMY109. Since the launch of TOP I 2030 in 2021, we have continuously generated new projects and built technological foundations through enhanced RED functions. The number of early-stage projects has been increasing, with nine in-house projects entering clinical development over the four-year period. For early-stage clinical development pipeline, we have prioritized in-house projects after considering obtained data and the current portfolio situation, resulting in the decision to discontinue these five projects. Through this decision, we aim to maximize the success rate of achieving TOP I 2030 goals through dynamic and strategic allocation of resources to priority projects.

*Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

For products in-licensed from Roche, Elevidys has obtained regulatory approval as a regenerative medicine product for the treatment of Duchenne muscular dystrophy under the conditional and time-limited approval pathway in Japan. Vabysmo has received approval for an additional indication for angioid streaks, and Evrysdi has launched a new formulation in Japan. Lunsumio has been filed for an additional indication in combination with Polivy for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and Tecentriq has been filed for an additional indication for unresectable thymic cancer. Additionally, Vabysmo (for non-proliferative diabetic retinopathy) and inavolisib (for PIK3CA mutated breast cancer) have initiated new clinical trials.

[2025 second quarter results]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Core results
Revenue 578.5 552.9 +4.6%
　Sales 511.4 485.5 +5.3%
　Other revenue 67.0 67.3 -0.4%
Operating profit 272.0 262.8 +3.5%
Net income 193.5 189.5 +2.1%
IFRS results
Revenue 578.5 552.9 +4.6%
Operating profit 273.3 258.2 +5.8%
Net income 194.4 186.3 +4.3%
[Sales breakdown]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Sales 511.4 485.5 +5.3%
Domestic sales 223.3 217.2 +2.8%
　Oncology 116.6 118.8 -1.9%
　Specialty 106.7 98.4 +8.4%
Overseas sales 288.1 268.4 +7.3%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Tecentriq 29.9 31.1 -3.9%
Polivy 17.0 15.7 +8.3%
Alecensa 15.8 14.9 +6.0%
Phesgo 15.4 8.6 +79.1%
Avastin 13.0 17.4 -25.3%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Hemlibra 29.1 27.4 +6.2%
Actemra 23.8 22.4 +6.3%
Enspryng 13.3 11.6 +14.7%
Vabysmo 12.0 9.1 +31.9%
Evrysdi 7.9 7.5 +5.3%
[Progress in R&D activities from Apr 25th, 2025 to Jul 24th, 2025]

2025 Q2 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On July 23, 2025 Boston Scientific Corporation reported the company generated net sales of $5.061 billion during the second quarter of 2025, growing 22.8 percent on a reported basis, 21.6 percent on an operational1 basis and 17.4 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 23, 2025, View Source [SID1234656859]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $797 million or $0.53 per share (EPS), compared to $324 million or $0.22 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.62 a year ago.

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"This was another excellent quarter — marked by exceptional top-line performance — that delivered margin expansion and prioritized investment for future growth," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am incredibly grateful to our dedicated global team for demonstrating clinical and commercial excellence across the company and positioning us for differentiated long-term performance."

Second quarter financial results and recent developments:

Reported net sales of $5.061 billion, representing an increase of 22.8 percent on a reported basis, compared to the company’s guidance range of 17.5 to 19.5 percent; 21.6 percent on an operational basis; and 17.4 percent on an organic basis, compared to the company’s guidance range of 13 to 15 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.53 per share, compared to the company’s guidance range of $0.45 to $0.47 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.71 to $0.73 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 15.7 percent reported, 14.7 percent operational and 7.0 percent organic
Cardiovascular: 26.8 percent reported, 25.5 percent operational and 23.2 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 6.8 percent reported and 1.8 percent operational
Asia-Pacific (APAC): 18.0 percent reported and 15.4 percent operational
Latin America and Canada (LACA): 4.0 percent reported and 8.9 percent operational
Emerging Markets4: 11.6 percent reported and 12.1 percent operational

Received U.S. Food and Drug Administration approval to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF) with the FARAPULSE Pulsed Field Ablation (PFA) System.

Commenced enrollment in the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE and FARAPOINT PFA Catheters in patients with persistent AF who previously received a cardiac ablation and experienced a recurrence of the condition.5

Received CE mark for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.

Completed the acquisition of Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.

Completed the acquisition of SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational renal nerve denervation technology designed to treat hypertension.5
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4. Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

5. The FARAPOINT PFA Catheter and the TIVUS Intravascular Ultrasound System are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.