# FDA Grants Accelerated Approval to Linvoseltamab (Lynozyfic) for Relapsed/Refractory Multiple Myeloma

> fda · REPORTED · 2025-07-02

On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, a CD38-targeting antibody, and an immunomodulatory agent. This adds a new bispecific antibody option to the heavily pretreated myeloma treatment landscape.

About Regeneron / linvoseltamab: Linvoseltamab (Lynozyfic) is a bispecific antibody targeting BCMA and CD3, developed as a T-cell redirecting therapy for patients with relapsed or refractory multiple myeloma who have exhausted standard treatment options.

- Company: Regeneron / linvoseltamab
- Sector: oncology
- Primary source: https://www.oncnursingnews.com/view/july-fda-oncology-approvals-include-options-for-nsclc-myeloma-and-more

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.