Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma.
Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) 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 1/II pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023. A Biologics License Application (BLA) was also submitted to the FDA in December 2023.
The linvoseltamab clinical development program includes a Phase III confirmatory trial (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a Phase 1/II trial in the first-line setting, a Phase II trial in high-risk smoldering MM and a Phase II trial in monoclonal gammopathy of undetermined significance.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.