USFDA approves Libtayo for skin cancer treatment

The US Food and Drug Administration (FDA) has approved Libtayo to be used for the treatment of patients having two of the most common skin cancers in the US.

Jointly developed under a global collaboration agreement by Sanofi and Regeneron, Libtayo (or cemiplimab-rwlc in the US) is a PD-1 inhibitor, which will be used as the first immunotherapy for patients having advanced basal cell carcinoma (BCC) who had been treated with a hedgehog pathway inhibitor (HHI) earlier, or for whom HHI is not suitable.

Founded by physician-scientists over 30 years ago, biotechnology company Regeneron invents life-transforming drugs for the treatment of serious diseases, while Sanofi is a human health-focused global biopharmaceutical company.

Subsequent to USFDA Priority Review, Libtayo gets full approval in locally advanced BCC and accelerated approval in metastic BCC.

Sanofi Oncology and Pediatric Innovation Global Development head Peter Adamson 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.

“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.”

Libtayo is the first to exhibit positive clinical results in a pivotal trial for advanced BCC patients after HHI therapy.

University of Colorado Professor in the Division of Medical Oncology and a trial investigator Karl Lewis said: “The FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma. 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-tumor responses in locally advanced BCC.”

USFDA Priority Review is reserved for approved medicines that possess the potential to produce significant improvements, safely and effectively, while treating serious conditions.

In the US, this is the second such approval for Libtayo, which is a fully-human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T-cells.

Libtayo was first approved in 2018 for the systemic treatment of adult patients suffering from metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not suitable for curative radiation or surgery.

The focus of Libtayo’s extensive clinical programme is to exclusively target difficult-to-treat cancers.

The most common type of skin cancer in the US, approximately two million new cases of BCC are diagnosed every year.

Regeneron Translational and Clinical Sciences, Oncology senior vice-president Israel Lowy said: “With today’s approval, Libtayo is now approved for both advanced cutaneous squamous cell and basal cell carcinomas, building a strong foundation in dermato-oncology. 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.”

Continuation of Libtayo’s approval is dependent upon further verified, clinically benefiting data from the trial.