Regeneron wins EU nod for Libtayo in PD-L1 positive lung cancer
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Regeneron (NASDAQ:REGN) announced Friday that a group of EU medical experts recommended the marketing authorization of checkpoint receptor Libtayo with chemotherapy as a first-line option for PD-L1 positive non-small cell lung cancer (NSCLC).
Specifically, the European Medicines Agencyâs (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Libtayo along with platinum-based chemotherapy as first-line treatment for adults with advanced NSCLC with â¥1% PD-L1 expression.

Their decision will next be reviewed by the European Commission (EC) which will issue a final decision in the coming months.
In the U.S., Libtayo is indicated along with chemotherapy for advanced NSCLC, irrespective of the PD-L1 level, as a first-line option.
Regeneron (REGN) holds exclusive global rights for Libtayo after Sanofi (SNY) handed back its rights in 2022 for $900M upfront and other payments.