- The FDA has issued a Complete Response Letter (CRL) to Incyte Corporation (NASDAQ:INCY) marketing application seeking approval for retifanlimab in anal cancer.
- The application covers adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed or are intolerant of platinum-based chemotherapy.
- The agency has asked for additional data to demonstrate the clinical benefit of retifanlimab.
- Incyte is reviewing the letter and will discuss the next steps with the FDA.
- The application was based on data from the Phase 2 POD1UM-202 trial.
- In June, FDA’s Oncologic Drugs Advisory Committee voted 13-4 that a regulatory decision on retifanlimab should be deferred until further data are available from the POD1UM-303 trial in platinum-naïve advanced SCAC that is currently underway.
- Price Action: INCY shares closed at $79.30 on Friday.
- Related content: Benzinga’s Full FDA Calendar.
Oppenheimer Reinstates Outperform on Darden Restaurants, Maintains $175 Price Target
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