▎WuXiEdited by Kant Content Team
Regeneron Pharmaceuticals announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion.Recommended conditional marketing approval for the bispecific antibody therapy linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM).They have received at least three prior treatment regimens, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies, and have experienced disease progression after their last treatment. The European Commission is expected to announce its final decision in the coming months.
The positive opinion of the CHMP was supported by data from the pivotal clinical trial LINKER-MM1. The trial results, announced in December 2023, showedAt a median follow-up of 11 months, an objective response rate of 71% was observed in patients (n=117) treated with linvoseltamab at a dose of 200 mg in the Phase 1/2 clinical trial, with 46% achieving complete response or better.
As of the data cutoff, all patients receiving 200 mg of linvoseltamab experienced adverse events (AEs), with 85% of patients experiencing grade ≥3 AEs. The most common AE was cytokine release syndrome (CRS; 46%). Among CRS cases, the majority (35%) were grade 1, 10% were grade 2, and one case (1%) was grade 3 CRS.
Earlier this month, the FDA had accepted linvoseltamabBiologics License Application(BLA), expected to complete the review by July 10, 2025.
Linvoseltamab is a bispecific antibody designed to link B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3 expressed on the surface of T cells, promoting T-cell activation and cancer cell killing.Karen Rodriguez-Lorenc, M.D., global project head of Regeneron's linvoseltamab, previously told industry media Fierce Biotech that the incidence of CRS demonstrated by linvoseltamab is in the "lower range" among comparable drugs. As linvoseltamab is administered intravenously, CRS cases occur at an earlier time point post-treatment, allowing for easier monitoring and care. Additionally, the drug’s response rate is within the "higher range" of its class, positioning linvoseltamab as a potential “best-in-class” bispecific antibody targeting BCMA and CD3.
▲To learn more about the application of cutting-edge technologies in the biopharmaceuticals industry, please long-press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.
[1] Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma. Retrieved February 28, 2025, from https://www.globenewswire.com/news-release/2025/02/28/3034628/0/en/Linvoseltamab-Recommended-for-EU-Approval-by-the-CHMP-to-Treat-Relapsed-Refractory-Multiple-Myeloma.htmlDisclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.Copyright Statement: This article is from the WuXi AppTec content team. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the "WuXi AppTec" WeChat Official Account to obtain reprint guidelines.
Share，PointLike，In View, Focusing on Global Biomedical Health Innovation
