Incyte notched a win today, March 23rd, with accelerated approval for retifanlimab, its treatment for a rare, aggressive skin cancer called Merkel cell carcinoma. The approval comes after patients single-arm study achieved a 52% response rate, with 18% seeing a complete response. These responses were durable out to almost 25 months in some patients.
According to Nicole Defeudis, “Incyte failed to win an approval for the drug in SCAC based on a single-arm study back in 2021, with members of the FDA’s Oncologic Drugs Advisory Committee voting 13-4 against a regulatory decision until more data could be collected from a placebo-controlled trial. Richard Padzur, director of the FDA’s Oncology Center of Excellence, said during the meeting that regulators had ‘profound concerns’ over approving checkpoint inhibitors on single-arm trials, then collecting placebo-controlled data afterward.”
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(Source: Endpoints News, March 22nd, 2023)