20 August 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued a complete response letter for the biologics license application for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies.

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 re-inspection by the FDA, and it is expected to take place in the coming months.

Read Regeneron Pharmaceuticals press release