# FDA Approves Regeneron's Linvoseltamab (Lynozyfic) for Relapsed or Refractory Multiple Myeloma

> fda · REPORTED · 2025-07-02

The FDA approved linvoseltamab (Lynozyfic), a B-cell maturation antigen bispecific antibody from Regeneron, on July 2, 2025 for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The approval was based on data from the LINKER-MM1 trial, which showed a 70% overall response rate among heavily pretreated patients.

About Regeneron: Regeneron is a large-cap biopharmaceutical company that discovers, develops, and commercializes medicines for serious diseases, including oncology, ophthalmology, and immunology, serving patients worldwide through hospital and specialty pharmacy channels.

- Company: Regeneron
- Sector: therapeutics
- Primary source: https://www.ajmc.com/view/5-hot-fda-approval-dates-that-made-waves-across-therapeutic-areas-in-july

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