BRIEF—Regeneron’s MAA for linvoseltamab accepted

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by USA-based Regeneron Pharmaceuticals for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies.

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

The MAA is supported by data from a Phase I/II pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM. A Biologics License Application (BLA) was also submitted to the Food and Drug Administration (FDA) in December 2023.

As the second most common blood cancer, there are over 176,000 new cases of MM diagnosed globally every year, Regeneron noted.

Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.