EMA committee recommends expanded approval of Regeneron's Libtayo for cervical cancer
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Regeneron Pharmaceuticals (NASDAQ:REGN) on Friday said that a panel of the European Medicines Agency (EMA) recommended the expanded approval of Libtayo (cemiplimab) as a monotherapy to treat adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

In June, Sanofi (NASDAQ:SNY) said it was selling worldwide exclusive license rights to Libtayo to Regeneron for $900M upfront, plus royalties and other potential payments.
The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was supported by data from a phase 3 trial called EMPOWER-Cervical 1.
The European Commission, which generally follows the opinion of the CHMP, will now decide on the drug's expanded approval.
Libtayo is currently approved in the EU and certain other countries to treat certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced non-small cell lung cancer.