Regeneron’s linvoseltamab MAA Filing Accepted by EMA; BLA Submitted to FDA for Multiple Myeloma

Regeneron announced that its marketing authorisation application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM), was accepted for review by the European Medicines Agency (EMA).  The MAA is supported by data from a Phase I/II trial (LINKER-MM1) investigating linvoseltamab in R/R MM.  Regeneron also submitted a Biologics License Application (BLA) to the FDA in December 2023.