FDA AdCom negative on Incyte's retifanlimab

Shares of US biotech Incyte (Nasdaq: INCY) closed down a modest 1.2% at $86.13 yesterday, after it announced the negative outcome of a meeting of the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC), which reviewed the Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor.

The filing was for the use of retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

Decision should be deferred until further data are available