Novel Therapy Granted Priority Review By FDA for Treatment of Anal Cancer Subset

The Food and Drug Administration (FDA) recently granted priority review to the biologics license application for retifanlimab for the treatment of adults with locally advanced or metastatic squamous cell carcinoma of the anal canal who did not tolerate, or whose disease progressed while receiving, platinum-based chemotherapy, according to Incyte, the agent’s manufacturer.

“Patients with (squamous cell carcinoma of the anal canal) who have progressed after firstline chemotherapy treatment currently have no approved treatments available, and we are encouraged that the FDA’s acceptance of this (biologics license application) for priority review brings us one step closer to addressing this historically neglected, yet important, tumor,” Dr. Lance Leopold, group vice president of Immuno-Oncology Clinical Development at Incyte, said in the release. “Despite (squamous cell carcinoma of the anal canal) being a rare disease, its incidence is increasing, and its impact is profound.”

The filing was based on results of the single-arm, multi-center phase 2 POD1UM-202 trial, in which treatment with retifanlimab induced a objective response (complete or partial responses to therapy) in some previously treated patients with locally advanced or metastatic squamous cell carcinoma of the anal canal.

The trial comprised 94 patients, including several with well-controlled HIV infection. Data, which was recently presented at a medical conference, indicated that monotherapy with the PD-L1 inhibitor led to an objective response rate of 14% in patients within the trial. Fatigue and diarrhea were the most common (more than 20%) side effects associated with treatment.

Squamous cell carcinoma of the anal canal accounts for approximately 3% of digestive system cancers and is associated with HPV and HIV infections, according to the release. The manufacturer notes that there are no FDA-approved treatments for those whose disease has progressed after receiving chemotherapy at the onset of disease.

The agency is set to make its decision on whether to approve the therapy by the end of July 2021.

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