On August 20, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. 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 (Press release, Regeneron, AUG 20, 2024, View Source [SID1234646033]). This anticipated outcome was previously disclosed during Regeneron’s second quarter 2024 earnings call.

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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.

Regeneron is committed to working closely with the third-party fill/finish manufacturer and the FDA to bring linvoseltamab to appropriate patients with R/R MM as quickly as possible, which is critical because most MM patients relapse and ultimately require additional therapies in late-line settings.

Regulatory review of linvoseltamab remains ongoing by the European Medicines Agency (EMA) in the same indication. Linvoseltamab is investigational, and its safety and efficacy have not been approved by any regulatory authority.