News from the FDA/CDC

FDA approves cemiplimab for advanced cutaneous squamous cell carcinoma


The U.S. Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma, the agency announced in a press release.

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The monoclonal antibody drug – a checkpoint inhibitor that blocks the PD-1 pathway – is the first treatment to be approved specifically for advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or curative radiation.

The approval was granted based on data from two open-label clinical trials involving a total of 108 patients: the phase 2 EMPOWER-CSCC-1 trial (NCT02760498) and two expansion cohorts from an open-label, nonrandomized phase 1 trial.

These trials, which included 75 patients with metastatic disease and 33 with locally advanced disease, found an overall response rate of 47.2%, and most of those patients still showed ongoing responses at the time of data analysis. Among patients with metastatic disease, 5% had a complete response, according to a press release from the manufacturer, Sanofi.

This is the sixth FDA approval for a checkpoint inhibitor targeting the PD-1/PD-L1 pathway. The drug was evaluated under the FDA’s Priority Review program for drugs that represent significant improvements in the safety or effectiveness of treatments for serious conditions. Manufacturer Sanofi was granted Breakthrough Therapy designation for cemiplimab in 2017 for advanced cutaneous squamous cell carcinoma, and the drug is also being reviewed by the European Medicines Agency.

Cemiplimab is administered as a 350-mg intravenous therapy every 3 weeks – costing $9,100 per treatment – until the disease progresses or patients experience unacceptable toxicity, according to the manufacturer. The most common side effects include fatigue, rash and diarrhea, but more serious adverse events can include immune-mediated reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin and kidney problems.

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