FDA Reviews Linvoseltamab BLA for Relapsed/Refractory Multiple Myeloma Treatment

Regeneron Pharmaceuticals, Inc., based in Tarrytown, New York, has announced that the U.S. Food and Drug Administration (FDA) has accepted a resubmitted Biologics License Application (BLA) for linvoseltamab. This application pertains to the treatment of adult patients who have relapsed or are battling refractory multiple myeloma (MM) and have undergone at least four prior therapies or three therapies and are resistant to the most recent one. The FDA is expected to make a decision regarding this application by July 10, 2025.

The resubmission was made possible after Regeneron addressed a third-party fill/finish manufacturing issue, which was the only obstacle in the previous submission. The BLA resubmission is backed by data from the pivotal LINKER-MM1 trial, which investigates linvoseltamab in patients with relapsed/refractory multiple myeloma. This investigational drug is also under review by the European Medicines Agency (EMA) for the same patient group.

Multiple myeloma is recognized as the second most common blood cancer, with more than 187,000 new cases emerging worldwide annually. In the United States alone, over 36,000 diagnoses and 12,000 deaths are expected in 2025. The disease is characterized by the uncontrolled growth of cancerous plasma cells that can infiltrate bone marrow, displace healthy blood cells, spread to other tissues, and lead to severe organ damage. Despite advancements in treatment, multiple myeloma remains incurable. Current therapies can slow the disease's progression, yet many patients experience disease advancement and need further treatment.

Linvoseltamab, still under investigation and not yet approved by any regulatory body, is a bispecific antibody designed to connect B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells, promoting T-cell activation and the destruction of cancer cells. The LINKER-MM1 trial is a multicenter, open-label Phase 1/2 study exploring the drug's efficacy in 282 patients. The Phase 1 section, now completed, primarily assessed the safety and tolerability of linvoseltamab across nine doses and various administration regimens. The ongoing Phase 2 part is examining the drug's safety and tumor-fighting capabilities, with the primary goal being the objective response rate. Secondary goals include the duration of response, progression-free survival, and overall survival.

To qualify for the Phase 2 study, patients must have previously received at least three therapies or have triple-class refractory multiple myeloma. Linvoseltamab is initially administered with a step-up dosing plan, reaching a full 200 mg dose weekly. By the 16th week, patients transition to receiving doses every two weeks. Those showing a very good partial response or better, after completing 24 weeks of therapy, can switch to a dosing schedule of every four weeks. The treatment requires patients to stay in the hospital twice for 24 hours for safety monitoring.

Regeneron's broader linvoseltamab clinical development program explores its application both as a standalone therapy and in combination with other treatments across different stages of multiple myeloma, including earlier treatment lines and precursor disorders. This includes a Phase 1b trial that combines linvoseltamab with other cancer therapies and a Phase 3 trial evaluating it as a monotherapy.

Regeneron is leveraging its VelociSuite® technologies to enhance its offerings in hematology, focusing on bispecific antibodies both as single agents and in combination with other treatments. These efforts aim to provide innovative and flexible cancer treatment options. The company is also employing advanced technologies such as VelocImmune® to develop fully human antibodies and has made significant contributions to the medical field with several FDA-approved therapies.