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FDA grants priority review to cemiplimab for advanced cutaneous squamous cell carcinoma
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The FDA granted priority review to cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or those with locally advanced disease who are not candidates for surgery.
The FDA previously granted breakthrough therapy designation to cemiplimab (REGN2810; Regeneron, Sanofi), an investigational human monoclonal antibody that targets PD-1.
The FDA based the priority review designation on data from the phase 2 single-arm, open-label EMPOWER-CSCC 1 trial, as well as data from two phase 1 expansion cohorts. In those trials, researchers enrolled patients with metastatic cutaneous squamous cell carcinoma and patients with locally advanced disease who were not candidates for surgery.
In the EMPOWER-CSCC 1 trial, researchers reported an independent review-assessed overall response rate of 46.3% among 82 cemiplimab-treated patients.
The safety profile appeared consistent with other approved anti-PD-1 therapies.
Researchers will present results from these trials at the ASCO Annual Meeting, scheduled for June 1-5 in Chicago.
The FDA set an action date of Oct. 28.