US FDA declines to approve Regeneron's therapy for common blood cancer

FDA, in a so-called 'complete response letter', said that the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer

The U.S. Food and Drug Administration has declined to approve Regeneron's therapy for a common form of blood cancer, the company said on Tuesday.
 

Regeneron was seeking regulatory approval of its therapy, linvoseltamab, in patients with multiple myeloma whose cancer has returned or worsened after at least three prior lines of treatment.
 

The FDA, in a so-called "complete response letter", said the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer, the company said.
 

Regeneron said it is committed to working closely with the third-party manufacturer and the health regulator to bring linvoseltamab to patients, without giving any other details.
 

Regeneron said in early August that the FDA's concerns about a third-party manufacturer will cause a delay in the regulatory decision for linvoseltamab, even though the issues were resolved and unrelated to the drug's production.

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