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FDA grants accelerated approval to linvoseltamab for adult patients with R/R multiple myeloma after at least four prior lines of therapy

On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted approval to linvoseltamab, a B-cell maturation antigen (BCMA) and CD3-targeted bispecific antibody, for adult patients with relapsed/refractory (R/R) multiple myeloma who have progressed after at least four prior lines of therapy, including a proteasome inhibitor (PI), an anti-CD38 monoclonal antibody, and an immunomodulatory agent (IMiD).1

Multiple myeloma is the second most common type of blood cancer. The introduction of IMiDs, PIs, and CD38-targeting antibodies has extended patient survival; however, many patients experience treatment-related complications, and as an incurable condition, most eventually experience disease progression and require additional lines of therapy.2

The approval of linvoseltamab is based on results from the open-label, multi-center Phase I/II LINKER-MM1 trial (NCT03761108), which is investigating the safety and efficacy of linvoseltamab in patients with R/R disease. In an efficacy-evaluable cohort of 80 patients, an overall response rate of 70% (95% CI: 59, 80) was observed, with 45% of patients achieving a complete response or better. At a median follow-up of 11.3 months, the estimated duration of response was 89% (95% CI: 77, 95) at nine months and 72% (95% CI: 54, 84) at 12 months.1,3

Among patients who received linvoseltamab, 46% experienced cytokine release syndrome (CRS). Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, was reported in 54% of patients in this treatment arm. Grade 3 CRS was observed in less than 1% of patients, while Grade 3 or 4 neurologic toxicity was observed in 8%. Other adverse events and precautions for linvoseltamab include infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.1,3

We recently spoke with Hans Lee, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, who shared insights into the initial results of the LINKER-MM1 trial, as well as the potential approval of this agent in 2025. He stated, “The original LINKER-MM1 study was a pivotal Phase I/II study for relapsed/refractory multiple myeloma… And the responses were quite impressive… Over half of patients had a complete response or better. This is a very promising drug for multiple myeloma.”

The approval of this agent provides a new treatment option for patients with R/R multiple myeloma, addressing a significant area of unmet need and potentially expanding therapeutic choices in later lines of care.

References

  1. U.S. Food and Drug Administration. FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma. Available here. (Last accessed 03/07/2025).
  2. van de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427.
  3. Regeneron. Lynozyfic™ (linvoseltamab-gcpt) receives FDA accelerated approval for treatment of relapsed or refractory multiple myeloma. Available here. (Last accessed 03/07/2025).

Written by Manon Chataignier

Edited by Anya Dragojlovic Kerkache & Raffaella Facchini