FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
Key Takeaways REGN gained FDA approval for Lynozyfic to treat relapsed or refractory multiple myeloma. Lynozyfic showed a 70% response rate and 45% complete response rate in the LINKER-MM1 trial. The approval makes Lynozyfic the first FDA-cleared BCMAxCD3 bispecific with biweekly or monthly dosing.Regeneron Pharmaceuticals, Inc. (REGN) obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).The regulatory body granted accelerated approval to lin ...