Cemiplimab (Libtayo) is now approved by the FDA to treat patients with basal cell carcinoma (BCC) following treatment with a hedgehog pathway inhibitor (HHI) or for whom these therapies are not appropriate, according to Regeneron Pharmaceuticals and Sanofi – the drug’s manufacturers.
The fully human monoclonal antibody targeting PD-1 is approved at the recommended dose of 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
“Today’s FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma,’ Karl Lewis, MD, professor in the Division of Medical Oncology at the University of Colorado as well as a trial investigator, said in a press release. “Advanced basal cell carcinoma is a persistent, painful, and highly disfiguring cancer. While the primary…
