Regeneron’s Linvoseltamab BLA Receives CRL for Third-Party Manufacturing Issue

Regeneron Pharmaceuticals, Inc. announced today that the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). Previously, at Regeneron's second quarter 2024 earnings call, this expected result was revealed.

The only approvability problem found has to do with what was discovered during a pre-approval examination at a third-party fill/finish manufacturer for a product candidate belonging to a different business. Since then, Regeneron has received word from the third-party fill/finish manufacturer that the concerns have been addressed, that the FDA is waiting to re-inspect their facilities, and that this should happen in the upcoming months.

Linvoseltamab will soon be available to eligible patients with R/R MM, according to Regeneron's commitment to close collaboration with the FDA and third-party fill/finish manufacturer. This is important because the majority of MM patients relapse and eventually need additional therapies in late-line settings.

The European Medicines Agency (EMA) is still reviewing linvoseltamab's regulatory status for the same indication. No regulatory body has given linvoseltamab's safety or effectiveness the green light; it is still an experimental medication.