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Regeneron Pharmaceuticals announced today,The U.S. FDA has granted accelerated approval to the bispecific antibody Lynozyfic (linvoseltamab) for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM).These patients had previously received at least four treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This therapy can be administered once every two weeks starting from week 14 of treatment; if patients achieve a very good partial response (VGPR) or better after completing at least 24 weeks of treatment, the dosing frequency can be adjusted to once every four weeks.

The FDA approval was primarily based on the pivotal Phase 1/2 LINKER-MM1 trial results, which evaluated the efficacy of linvoseltamab in treating R/R MM, with a total of 80 patients enrolled.

The results assessed by the Independent Review Committee (IRC) showed that,The objective response rate (ORR) of the patients reached 70%, with 45% of the patients achieving a complete response (CR) or better.The median time to first response was 0.95 months (range: 0.5 to 6 months). Additionally, the median duration of response (DoR) has not yet been reached (95% CI: 12 months to not estimable). In responders with a median follow-up of 13 months, the estimated 9-monthRate of sustained reliefWas 89% (95% CI: 77-95), 12 monthsRate of sustained relief72% (95% CI: 54-84).

Linvoseltamab is a BCMA/CD3-targeted bispecific antibody., which aims to connect BCMA on multiple myeloma cells with CD3 expressed on the surface of T cells, thereby promoting T cell activation and cancer cell killing.

References:

[1] Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma. Retrieved July 2, 2025 from https://www.globenewswire.com/news-release/2025/07/02/3109328/0/en/Lynozyfic-linvoseltamab-gcpt-Receives-FDA-Accelerated-Approval-for-Treatment-of-Relapsed-or-Refractory-Multiple-Myeloma.html

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