EMA Review: Linvoseltamab for r/r Multiple Myeloma Treatment

Regeneron Pharmaceuticals, Inc. published a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the treatment of elderly patients with relapsed/refractory (R/R) multiple myeloma (MM). It was announced that it was approved. For review. At least three previous treatments. Rinvoseltamab is a bivalent antibody that causes T-cell activation and cancer death by binding to B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3-expressing T cells.

MAA is supported by data from a phase 1/2 trial (LINKER-MM1) investigating linboseltamab in R/R MM, last distributed in December 2023. A biologics license application (BLA) has also been submitted) to the FDA.

It is the second most common blood cancer, with more than 176,000 new cases of MM diagnosed each year worldwide. This is a sign of the growth of cancerous plasma cells (MM) displacing healthy blood cells from the bone marrow, invading other tissues and possibly causing organ failure. Despite advances in treatment, MM remains incurable. Although current treatments can slow cancer progression, most patients experience disease progression and seek additional treatment.

The clinical development program for linvoseltamab now includes a confirmatory phase 3 trial (LINKER-MM3). Additional clinical trials are planned for first-line treatment and disease stages, including a Phase 1/2 trial for first-line treatment, a Phase 2 trial for high-risk MM, and a Phase 2 trial for unknown monoclonal gammopathy. Progress importance: A phase 1 trial is also planned to combine linboseltamab with a bispecific CD38xCD28 costimulatory drug in MM.Rinvoseltamab is currently in clinical development, and regulatory authorities have not thoroughly evaluated its safety and efficacy.