Benzinga | Jul 26, 2021 06:29AM EDT

FDA Strikes Off Incyte's Retifanlimab Application In Anal Cancer

* 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-na?ve advanced SCAC that is currently underway.

* Price Action: INCY shares closed at $79.30 on Friday.

* Related content: Benzinga's Full FDA Calendar.