The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voiced support for approving Sanofi’s and Regeneron’s monoclonal antibody Libtayo (cemiplimab) for advanced nonsmall-cell lung cancer (NSCLC) and advanced basal-cell carcinoma.

The committee recommended approving Libtayo, a PD-1 inhibitor, for the first-line treatment of adult NSCLC patients who express PD-L1 in 50 percent or more of their tumor cells with no EGFR, ALK or ROS1 gene aberrations. The lung cancer patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation, the committee recommended.

The CHMP also gave a positive opinion for approving Libtayo for adults with locally advanced or metastatic basal-cell carcinoma (BCC) who have progressed on or cannot tolerate a hedgehog pathway inhibitor. To date, the committee has given the drug three positive opinions for advanced cancers.

A decision from the European Commission on whether to approve Libtayo for the two cancer indications is expected in the coming months.