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# Regeneron’s Lynozyfic Approved for Some Myelomas
- URL: https://www.fdaweb.com/regenerons-lynozyfic-approved-for-some-myelomas/
- Published: 2025-07-07T12:00:00.000Z
- Updated: 2026-09-14T15:15:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159446

FDA has given accelerated approval to Regeneron’s Lynozyfic (linvoseltamab-gcpt), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. An agency [notice](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma?ref=fdaweb.com) says the drug’s efficacy was evaluated in the LINKER-MM1 trial that included 80 patients who had received at least four prior lines of therapy.

Efficacy was based on the objective response rate, which was 70%. The labeling includes a Boxed Warning for life-threatening cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.

Because of its risks, Lynozyfic is available only through a restricted program under a Risk Evaluation and Mitigation Strategy, FDA says. Other Warnings and Precautions include infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.

The application was granted a priority review and received orphan drug and fast-track designations.