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02-10-2018 | FDA | News


First advanced cutaneous squamous cell carcinoma drug approved

medwireNews: The US FDA has approved use of the PD-1 inhibitor cemiplimab-rwlc for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced disease who are unable to undergo surgery or radiotherapy with curative intent.

The first drug to be approved specifically for CSCC, cemiplimab-rwlc has been granted both Breakthrough Therapy and Priority Review status following results from the phase II EMPOWER-CSCC-1 study and two advanced expansion cohorts from a phase I trial. Overall, 47% of 108 patients with locally advanced or metastatic disease experienced at least a partial response to treatment.

The drug is recommended at a dose of 350 mg over a 30-minute intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. Adverse events reported include fatigue, rash, and diarrhea, as well as immune-mediated reactions such as pneumonitis and colitis.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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