▎WuXiEdited by Kant Content Team

Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted its resubmitted Biologics License Application (BLA) for linvoseltamab, a bispecific antibody therapy, intended for the treatment of adult patients with relapsed/refractory multiple myeloma (MM) who have received at least four prior lines of therapy or have received three prior lines of therapy and are refractory to their last line of treatment.The FDA is expected to make a regulatory decision on this application by July 10, 2025.Linvoseltamab is also under review by the European Medicines Agency (EMA) for the same patient population.

Linvoseltamab is designed to target multiple myeloma cells onBCell Maturation Antigen (BCMA）Bispecific antibodies that bridge T cells expressing CD3 to promote T cell activation and cancer cell killing.The acceptance of this BLA resubmission follows Regeneron's resolution of third-party fill/finish manufacturing issues, which was the only problem raised by the FDA in the company’s previous BLA submission.This BLA is supported by critical data from the LINKER-MM1 trial, which evaluated the efficacy of linvoseltamab in patients with relapsed/refractory multiple myeloma.

The trial results published in December 2023 showed that the median follow-up time was 11 months.In the phase 1/2 clinical trial (n=117), patients treated with linvoseltamab at a dose of 200 mg showed an objective response rate of 71%, with 46% achieving complete response or better.

As of the data cutoff, all patients receiving the 200 mg treatment experienced adverse events (AEs), with 85% of patients experiencing grade ≥3 adverse events (AEs).The most frequently occurring AE was cytokine release syndrome (CRS;46%）。In CRS cases, the majority (35%) were Grade 1, 10% were Grade 2, and one case (1%) was Grade 3 CRS.

Karen Rodriguez-Lorenc, M.D., global project head of Regeneron's linvoseltamab, previously told industry media Fierce Biotech that the incidence of CRS demonstrated by linvoseltamab is in the "lower range" among comparable drugs. Since linvoseltamab is administered intravenously, CRS cases occur earlier post-treatment, allowing for easier monitoring and care. Additionally,The response rate of this drug is in the "higher range" among similar drugs, positioning linvoseltamab as a potential "best-in-class" bispecific antibody targeting BCMA and CD3.