Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for linvoseltamab. This investigational bispecific antibody targets relapsed/refractory (R/R) multiple myeloma (MM) in patients who have progressed after at least three prior therapies. The CRL was disclosed during Regeneron’s second quarter 2024 earnings call.
The FDA's decision is based on findings from a pre-approval inspection at a third-party fill/finish manufacturer. The inspection was for another company’s product candidate and is not directly related to linvoseltamab itself. Regeneron reports that the third-party manufacturer believes these issues have been resolved and is awaiting reinspection by the FDA in the coming months.
Regeneron is working with the third-party manufacturer and the FDA to address the concerns raised in the CRL. The company aims to bring linvoseltamab to patients with R/R MM as quickly as possible, recognizing the critical need for additional therapies in late-line settings where most patients relapse and require further treatment.
Ongoing Regulatory Review
While the FDA review faces delays, the European Medicines Agency (EMA) continues its regulatory review of linvoseltamab for the same indication. Linvoseltamab remains an investigational agent, and its safety and efficacy have not been established or approved by any regulatory authority.
About Linvoseltamab
Linvoseltamab is a bispecific antibody designed to target B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, bridging them to induce T-cell mediated killing of myeloma cells. It is being developed as a potential treatment option for patients with relapsed or refractory multiple myeloma who have exhausted other available therapies.
Multiple Myeloma Treatment Landscape
Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. Despite advances in treatment, it remains an incurable disease for many patients. Current treatment approaches include chemotherapy, proteasome inhibitors, immunomodulatory drugs, and stem cell transplantation. However, many patients eventually relapse or become refractory to these therapies, highlighting the need for new treatment options like linvoseltamab.
