FDA Delays Approval of Regeneron’s Multiple Myeloma Drug Due to Manufacturing Issues

FDA Rejection:
The FDA has issued a complete response letter (CRL) to Regeneron Pharmaceuticals for its bispecific antibody, linvoseltamab, intended for the treatment of relapsed or refractory multiple myeloma. The rejection is due to manufacturing issues at a third-party fill/finish facility, not related to the drug's safety or efficacy.

Manufacturing Issues:
The third-party manufacturer believes the issues have been resolved, but the FDA requires a reinspection of the facility, expected to occur in the coming months.

Clinical Data:
Linvoseltamab has shown promising results in clinical trials, with a 71% objective response rate and a 46% complete response rate or better after a median follow-up of 11 months. Updated data with longer follow-up maintained these response rates.

Competitive Landscape:
Regeneron faces competition from Johnson & Johnson's Tecvayli and Pfizer's Elrexfio, both of which have received accelerated FDA approval for multiple myeloma treatment.

Regeneron's Response:
Regeneron is committed to working closely with the third-party manufacturer and the FDA to address the issues and bring linvoseltamab to market as quickly as possible.