Regeneron Pharmaceuticals has reached a crucial milestone as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending conditional marketing authorization for linvoseltamab. This investigational bispecific antibody is intended for the treatment of adults with relapsed and refractory multiple myeloma, particularly those who have undergone at least three prior therapies. These therapies must include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and these patients should have experienced disease progression following their last treatment.

The positive opinion from the CHMP is informed by results from the pivotal LINKER-MM1 clinical trial. This trial was focused on linvoseltamab's efficacy in adults with relapsed and refractory multiple myeloma. Additionally, linvoseltamab is still under review by the European Commission, with a final verdict expected within the next few months, as noted in the regulatory dossier from Regeneron's investor communications.

In the United States, the U.S. Food and Drug Administration accepted the Biologics License Application for linvoseltamab earlier this year. The FDA has set a target date of July 10, 2025, to complete its review. This progress represents a promising addition to the therapeutic arsenal for multiple myeloma, underscoring the importance of global regulatory actions in broadening treatment accessibility.