CHMP Backs Lynozyfic for Myeloma

Regeneron Pharmaceuticals, Inc.  announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. The European Commission is expected to announce a final decision in the coming months. The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. At 14-months median follow-up in the pivotal trial, 50% of patients achieved a complete response or better and a 71% overall response rate, as presented in an EHA oral presentation and simultaneously published in the Journal of Clinical Oncology .Earlier this month, the FDA accepted for review the Biologics License Application for linvoseltamab. The target action date for the FDA decision is July 10, 2025.

Citation: Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma; Authors: Naresh Bumma, MD, Joshua Richter, MD , Sundar Jagannath, MD  Hans C. Lee, MD  James E. Hoffman, MD, Attaya Suvannasankha, MD , Jeffrey A. Zonder, MD , …nd Madhav V. Dhodapkar, MD madhav.v.dhodapkar@emory.edu. Publication: Journal of Clinical OncologyVolume 42, Number 22. https://doi.org/10.1200/JCO.24.0100.