FDA AdCom In Favor Of Delaying Incyte's Retifanlimab Approval In Anal Cancer

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte Corporation's INCY retifanlimab until more data can be collected from a placebo-controlled trial.
The PD-1 therapy is due for a PDUFA date of 25 July after receiving a priority review earlier this year.
Incyte seeks to win approval for the candidate after treating 94 second-line patients with squamous carcinoma of the anal canal in a single-arm trial.
Incyte's study showed an overall response rate of just 14% among 94 patients. The FDA says they're unsure whether this would correspond to a clinical benefit in a larger, placebo-controlled trial.
The agency also noted the low numbers of Black, Hispanic, and HIV-positive patients who participated in the trial and whether a potential benefit would outweigh the risk of rare but potentially fatal, immune-related side effects.
See the FDA briefing documents here.
Price Action: INCY shares are up 0.56% at $86.61 in the premarket session on the last check Friday.