Regeneron's Lynozyfic Gains Accelerated FDA Approval For Heavily Pre-Treated Multiple Myeloma

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Regeneron Pharmaceuticals, Inc.’s (NASDAQ:REGN) Lynozyfic (linvoseltamab-gcpt) for adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy.

Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least ...