Libtayo Snags CHMP Recommendations for Advanced Cancers

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.