FDA Panel Says Incyte Should Conduct New Trial for Its Anal Cancer Drug

Incyte needs to complete another clinical trial of its proposed anal cancer treatment retifanlimab before the FDA should consider approving it, an agency advisory committee said last week.

The Oncologic Drugs Advisory Committee voted 13-4 that the FDA’s decision on the monoclonal antibody for the treatment of advanced or metastatic squamous carcinoma of the anal canal should be deferred until further data are available from an ongoing phase 3 trial. The results are expected during the fourth quarter of 2024.

The advisory committee shared the FDA’s concerns about a small trial that showed a response rate of just 14 percent.