Benzinga | May 24, 2021 08:11AM EDT

Regeneron-Sanofi's Libtayo Scores CHMP's Positive Opinion For Two Advanced Cancer Settings

* The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA's (NASDAQ: SNY) Libtayo (cemiplimab) as monotherapy in two advanced cancers.

* The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ?50% of tumor cells with no EGFR, ALK, or ROS1 aberrations.

* Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation.

* The positive opinion for Libtayo in advanced NSCLC is based on results from a Phase 3 trial. Results from the pivotal trial were published in The Lancet in February 2021.

* Libtayo was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed or are intolerant to a hedgehog pathway inhibitor (HHI).

* Libtayo is the first immunotherapy to receive a positive CHMP opinion for this indication, the company said.

* Libtayo is currently approved in the European Union and other countries to treat certain patients with advanced cutaneous squamous cell carcinoma (CSCC).

* Price Action: SNY stock closed at $53.82, and REGN closed at $506.72 on Friday.