Regeneron Pharmaceuticals, Inc. (REGN) announced that the U.S. Food and Drug Administration has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
These therapies include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
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. It can be dosed every two weeks starting at week 14.
The dosing interval can be extended to every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy.
