By Colin Kellaher


Regeneron Pharmaceuticals Inc. and Sanofi SA Monday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of Libtayo as monotherapy in a pair of advanced cancers.

The companies said the recommendations cover Libtayo for the first-line treatment of adults with non-small cell lung cancer expressing PD-L1 in >=50% of tumor cells with no EGFR, ALK or ROS1 aberrations and for adults with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.

Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly developing and commercializing Libtayo under a global collaboration agreement.

The European Commission, which generally follows the CHMP's advice, is expected to make a decision on both indications in the coming months, the companies said.


Write to Colin Kellaher at


(END) Dow Jones Newswires

May 24, 2021 06:13 ET (10:13 GMT)

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