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FDA approves Sanofi's Libtayo for advanced basal cell carcinoma

Published on 10/02/21 at 10:35am

The FDA has approved Sanofi’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.

Full approval was granted for patients with locally advanced BCC, and accelerated approval was granted for patients with metastatic BCC.

BCC is the most common skin cancer in the US, with around two million new cases diagnosed every year. While most BCCs are caught early and cured with surgery and radiation, a small proportion of tumours can become advanced, and penetrate deep into surrounding tissues or spread to other parts of the body, which makes them more difficult to treat.

Libtayo is the first treatment to show a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal trial. The full approval in locally advanced BCC is based on the primary analysis from the trial, and the accelerated approval in metastatic BCC is based on an interim analysis showing the impact of Libtayo on tumour response rate and durability of response.

The FDA’s approval of the drug was based on an open-label, multicentre, non-randomised Phase II trial of patients with unresectable, locally advanced BCC or metastatic BCC. This was the largest prospective clinical trial among this patient population, with 112 patients included in the efficacy analysis. Patients in both cohorts had either progressed on HHI therapy, had not had an objective response after nine months on HHI therapy, or were intolerant of prior HHI therapy.

The agency’s decision marks the second US 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. In 2018, the drug was approved as the first systemic treatment for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Peter Adamson, Global Development Head of Oncology and Pediatric Innovation at Sanofi, said: “Patients with advanced forms of basal cell carcinoma face a very difficult prognosis. 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 US affected by advanced BCC, another devastating non-melanoma skin cancer.”

Dr Karl Lewis, Professor in the Division of Medical Oncology at the University of Colorado, and a trial investigator, also commented: “Advanced basal cell carcinoma is a persistent, painful, and highly disfiguring cancer. While the primary systemic treatment options are hedgehog inhibitors, many patients will eventually progress on or become intolerant to this therapy.

“With Libtayo, these patients now have a new immunotherapy option that has demonstrated clinically meaningful and durable anti-tumour responses in locally advanced BCC.”

Darcy Jimenez

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