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 REGN and Sanofi SA's 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.