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Sanofi - Regeneron's Immunotherapy Scores European Approval For Skin And Lung Cancer Settings

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  • The European Commission (EC) has approved Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Libtayo (cemiplimab) for two additional indications - basal cell carcinoma (BCC) and non-small cell lung cancer with over 50% PD-L1 expression.

  • BCC (skin cancer) approval covers adults with locally advanced or metastatic disease who have progressed on or are intolerant to a hedgehog pathway inhibitor.

  • Concurrently, the Commission approved Libtayo for the first-line treatment of adult patients with advanced non-small-cell lung cancer whose tumor cells have over 50% PD-L1 expression and no EGFR, ALK, or ROS1 aberrations.

  • In 2019, Libtayo was approved by the EC as the first treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

  • Libtayo is now approved by the European Commission for three advanced cancers.

  • Price Action: REGN shares closed at $544.4, and SNY closed at $52.32 on Friday.

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