FDA Accepts Regeneron’s Linvoseltamab BLA For Relapsed Multiple Myeloma

Regeneron Pharmaceuticals gained FDA approval to resubmit linvoseltamab as a Biologics License Application (BLA) for relapsed/refractory multiple myeloma treatment in adults. The drug application is intended for patients who received four past treatment lines or three lines if they're resistant to the last treatment. The FDA established July 10th 2025, as the date to decide on linvoseltamab. Third-party manufacturing difficulties related to the fill/finish processes of the drug led Regeneron to resubmit its BLA application. 

Linvoseltamab undergoes FDA evaluation using LINKER-MM1 trial results that proved its effectiveness against R/R multiple myeloma. The European Medicines Agency (EMA) conducts a parallel review of linvoseltamab to treat the same patient population. The drug currently remains an investigational therapy and has not yet been approved by any regulatory authority.