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On Sept. 28, 2018, the Food and Drug Administration approved cemiplimab-rwlc (LIBTAYO, Regeneron Pharmaceuticals Inc.) for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Approval was based on clinically meaningful and durable objective response rates (ORR) observed in patients with advanced CSCC who were treated with cemiplimab-rwlc in two clinical trials: R2810-ONC-1423, an open-label, multi-center, dose-finding trial with expansion cohorts in patients with various advanced solid tumors; and R2810-ONC-1540, an open-label, multi-center, non-randomized, multicohort trial in patients with metastatic or locally advanced CSCC regardless of prior treatment, for whom surgery or radiation was not recommended. ORR was assessed by an independent review committee according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for patients with metastatic CSCC. A composite response assessment incorporating clinical response criteria using digital photography and RECIST 1.1 was used for those with locally advanced CSCC. More information here. Comments are closed.
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