Regeneron hit with CRL on linvoseltamab filing
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics license application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
This anticipated outcome was previously disclosed during the drug’s developer, Regeneron’s (Nasdaq: REGN) along with its second quarter 2024 earnings call. The BLA was accepted for priority review by the FDA in February last year.
The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate. The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months.
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