Posted by Michael Wonder on 28 Sep 2018
FDA approves first treatment for advanced form of the second most common skin cancer
28 September 2018 - New drug targets PD-1 pathway.
The U.S. FDA today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.
The safety and efficacy of Libtayo was studied in two open label clinical trials. A total of 108 patients (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced partial shrinkage or complete disappearance of their tumour(s) after treatment. Results showed that 47.2 percent of all patients treated with Libtayo had their tumours shrink or disappear. The majority of these patients had ongoing responses at the time of data analysis.
