Our editorials criticizing the Food and Drug Administration for torpedoing promising treatments must be hitting an intracranial nerve. Proof of their potency: Commissioner Marty Makary and his deputy Vinay Prasad devoted much of a recent FDA podcast to mischaracterizing them.
[The] spin doctors cried fake news rather than address the substantive arguments. If they really want to prove they’re not impeding life-saving treatments, they’ll approve Replimune’s RP1 immunotherapy for metastatic melanoma, which the agency rejected this summer.
An analysis by RBC Capital Markets last week reported “a potentially worrisome increase in drug approval delays of late that could signal deeper systemic challenges at the Agency.”
Rejections rose to 15% from an average of 10%, and delays to 11% from 4%. Some non-approvals owe to manufacturing problems, but another culprit is an agency brain drain.
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Related on the SLP
The drug last year received a “breakthrough” therapy designation from the agency after a pivotal trial showed that a third of patients who hadn’t responded to prior immunotherapy showed a strong response to RP1.
Melanoma doctors around the world have criticized the FDA rejection.
