Libtayo wins conditional approval in Europe

1 July 2019

Libtayo (cemiplimab) has been granted conditional approval for the treatment of certain adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), one of the most commonly diagnosed skin cancers worldwide.

The decision makes the product, which is being jointly developed by Sanofi (Euronext: SAN) and Regeneron (Nasdaq: REGN), the only approved checkpoint inhibitor in advanced CSCC in Europe. Libtayo was approved in the USA last September.

Updated results from the registrational EMPOWER-CSCC-1 trial were recently shared at the 2019 annual meeting of the American Society of Clinical Oncology annual meeting.

Investigator Axel Hauschild said: “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 who cannot be cured by surgery or radiation.”

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