The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC). Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.
Libtayo is the first treatment to show a clinical benefit in patients with advanced BCC. The full approval in locally advanced BCC is based on the primary analysis from the trial. The accelerated approval in metastatic BCC is based on an interim analysis showing the impact of Libtayo on tumor response rate and durability of response. Continued approval may be contingent on additional data from the trial verifying clinical benefit.
Peter Adamson, Global Development Head, Oncology and Pediatric Innovation at Sanofi said, “Thanks to the participation and support of researchers, clinicians, and patients around the world, we are proud to bring forward a new immunotherapy treatment option for appropriate patients in the U.S. affected by advanced BCC, another devastating non-melanoma skin cancer. Together with Regeneron, we continue to develop Libtayo in numerous clinical trials and settings, including as monotherapy and in combination with several other therapeutic approaches as part of our commitment to innovation towards meaningful treatment options for patients with significant unmet needs”.
This marks the second U.S. approval for Libtayo, and is based on FDA Priority Review, which is reserved for medicines that, if approved, would represent significant improvements in safety or efficacy in treating serious conditions.
BCC is the most common type of skin cancer in the U.S., with approximately two million new cases diagnosed every year. While majority of BCCs are caught early and cured with surgery and radiation, a small proportion of tumors can become advanced and penetrate deep into surrounding tissues which become more difficult to treat.
Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron said, “Beyond skin cancers, we also continue to investigate the potential of Libtayo in other difficult-to-treat cancers, starting with non-small cell lung cancer where an FDA decision is expected by the end of February”.
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