Sanofi, Regeneron's immunotherapy Libtayo approved in US for advanced cutaneous squamous cell carcinoma

Sanofi announced Friday that the FDA cleared Libtayo (cemiplimab-rwlc) 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. The company noted that the PD-1 inhibitor is the first treatment specifically approved for advanced CSCC in the US, where Sanofi will co-market the therapy with partner Regeneron.

The decision, which followed a priority review by the FDA, was based on data from the mid-stage EMPOWER-CSCC 1 trial, as well as two advanced CSCC expansion cohorts from the Phase I Study 1423. EMPOWER-CSCC 1 results, published in the NEJM this past June, showed that Libtayo-treated patients had a 47.5-percent response rate, including four complete responses and 24 partial responses, while the median duration of response, median progression-free survival, and median overall survival were not yet reached as of the data cut-off date. Sanofi noted that the efficacy analysis was conducted when all patients had the opportunity for at least six months of follow-up. 

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"In the US, CSCC accounts for one in five skin cancers, and the number of new diagnoses is increasing," noted Sanofi CEO Olivier Brandicourt, adding "we believe Libtayo has the potential to make a difference for US patients with advanced CSCC, as it helps to fill a critical gap in treatment options." Israel Lowy, Regeneron's vice president of global clinical development and head of translational science and clinical oncology, said the companies "remain focused on advancing our clinical research investigating Libtayo as a potential monotherapy and combination therapy in other cancer types." 

Libtayo, previously known as REGN281, has also received breakthrough therapy status from the FDA for the same indication. It was developed under a 2015 agreement between Sanofi and Regeneron that was expanded earlier this year. In December 2017, Sanofi disclosed that Libtayo would be among nine regulatory submissions it planned to file over the next 18 months.

The therapy is also under review by European regulators for patients with metastatic CSCC or those with locally advanced CSCC who are ineligible for surgery. 

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