Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA decision is August 22, 2024. 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 BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023. Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.

As the second most common blood cancer, it’s estimated 35,000 people will be diagnosed with MM in the U.S. every year. MM is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. MM is not curable despite treatment advances. While current treatments are able to slow the progression of the cancer, most patients will ultimately experience disease progression and require additional therapies.

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, including a Phase 1/2 trial in the first-line setting, a Phase 2 trial in high-risk smoldering MM and a Phase 2 trial in monoclonal gammopathy of undetermined significance. A Phase 1 trial of linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM is also planned.

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