Incyte Receives Complete Response Letter for Oncology Therapy

The FDA would like to see additional data on clinical benefit for patients with anal cancer.

The FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Incyte’s retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell anal cancer who have progressed on platinum-based chemotherapy.

The FDA’s letter follows recommendations from the Oncology Drugs Advisory Committee meeting on June 24, 2021, which suggested additional data was needed to demonstrate clinical benefit. The committee voted 13-4 against approving retifanlimab.

“While we are not surprised with the FDA decision given the ODAC recommendation, we are disappointed. We remain committed to advancing science to find solutions for patients with unmet medical needs, and we will ensure close coordination with the FDA in order to address feedback and determine next steps for the review of retifanlimab,” Hervé Hoppenot, chief executive officer of Incyte, said in a statement.

The BLA for retifanlimab is based on data from the phase 2 POD1UM-202 trial evaluating retifanlimab in 94 previously treated patients. Incyte announced results from this trial in September 2020, which found retifanlimab monotherapy resulted in a objective response rate of 14% as determined by independent central review.