FDA Strikes Off Incyte's Retifanlimab Application In Anal Cancer

The FDA has issued a Complete Response Letter (CRL) to Incyte Corporation 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.
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