The top regulator of cancer drugs at the Food and Drug Administration interceded during the late stages of a contentious review of a skin cancer therapy from Replimune Group — actions that contributed to the treatment’s last-minute rejection despite support from others inside the agency, STAT has learned.
The FDA has been riven by leadership changes, staff upheaval, and internal dysfunction, all of which also played part in the drug’s review and the decision to deny its approval. Replimune was largely caught in the middle.
The inside story of how Replimune’s drug, called RP1, came to be rejected was recounted to STAT by three FDA officials with direct knowledge of the matter. They all requested anonymity in order to speak freely about internal agency deliberations.
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