Regeneron: Linvoseltamab BLA To Treat RR/MM Accepted For FDA Priority Review

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) announced Wednesday that the U.S. Food and Drug Administration has accepted for Priority Review the Biologics License Application or BLA for linvoseltamab to treat relapsed/refractory multiple myeloma or R/R MM that has progressed after at least three prior therapies.

Multiple myeloma is the second most common blood cancer, and it is not curable despite treatment advances. According to the firm, current treatments are able to slow the progression of the cancer, while most patients will ultimately experience disease progression and require additional therapies.

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

The target action date for the FDA decision is August 22, 2024.

The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM. Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.

Regeneron noted that the linvoseltamab clinical development program includes a Phase 3 confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling.

Additional trials in earlier lines of therapy and stages of disease are planned or underway.

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

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