Grandbrothers/iStock Editorial via Getty Images The U.S. Food and Drug Administration (FDA) has denied approval of Regeneron Pharmaceuticals’ ( NASDAQ: REGN ) therapy for a form of blood cancer.
The New York-based biotech was seeking regulatory approval of its therapy, linvoseltamab, in relapsed/refractory multiple myeloma that has progressed after at least three prior lines of treatment. In a complete response letter for the therapy’s biologics license application, the FDA said the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate. This anticipated delay was previously disclosed during Regeneron’s Q2 earnings call.
“The FDA informed us that the third-party fill/finish manufacturer for linvoseltamab had unresolved findings from a preapproval inspection [...
] we anticipate any potential FDA approval for linvoseltamab is likely to be delayed beyond the August 22 PDUFA date. The FDA has not informed us of any approvability issues for linvoseltamab related to safety, efficacy, or the status of our ongoing confirmatory trial,” Regeneron said in the call. 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, the company said in the news release.
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