Regeneron Pharmaceuticals Secures FDA Accelerated Approval for Lynozyfic™ in Treating Relapsed or Refractory Multiple Myeloma

Reuters
2025/07/02
Regeneron Pharmaceuticals Secures FDA Accelerated Approval for Lynozyfic™ in Treating Relapsed or Refractory Multiple Myeloma

Regeneron Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for their drug Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. This approval is based on the response rate and durability of response observed in the LINKER-MM1 trial. Lynozyfic is poised to potentially become a new standard of care for multiple myeloma due to its 70% overall response rate in heavily pre-treated patients. Regeneron is also advancing a broad clinical development program to explore Lynozyfic's use in earlier lines of therapy and in novel combinations. The company is committed to supporting patients with Lynozyfic Surround™, providing financial and educational resources to aid patients throughout their treatment journey.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Regeneron Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9488442-en) on July 02, 2025, and is solely responsible for the information contained therein.

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