EU approves Sanofi, Regeneron's Libtayo for advanced cutaneous squamous cell carcinoma

Sanofi and Regeneron Pharmaceuticals announced Monday that the European Commission granted conditional approval for the PD-1 inhibitor Libtayo (cemiplimab) to treat adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. "With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer," said Axel Hauschild, an investigator in the pivotal CSCC clinical programme. 

As part of the conditional approval, Sanofi and Regeneron will add a new patient group to the Phase II EMPOWER-CSCC-1 trial to further support the benefit-risk profile of Libtayo. In recently updated results from the study, the therapy was associated with overall response rates of 44% in patients with locally advanced CSCC and 49% in patients with metastatic CSCC. Median overall survival was not yet reached in either group, while median progression-free survival was not yet reached among locally advanced CSCC patients, but was 18 months for those with metastatic disease.

Libtayo has been cleared for the same indication in the US, where it received breakthrough therapy status, as well as in Canada and Brazil. 

Sanofi and Regeneron jointly developed Libtayo, formerly known as REGN2810, under the terms of a 2015 agreement that was expanded last year. The drugmakers announced a restructuring of the partnership this past January that will allow Sanofi to exit the collaboration early.   

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