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Merck Stretches Lead As EU Approves Keytruda In First-Line NSCLC

 
• By Alexandra Shimmings

Merck & Co just keeps clearing the hurdles to checkpoint inhibitor market domination, with EU approval in the key first-line NSCLC indication coming swiftly after the company snuck in an earlier than expected filing in the US for its chemo combination use.

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Merck Sharp & Dohme Ltd. has received an expanded EU approval for its anti-PD1 product Keytruda (pembrolizumab) for first-line use in metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) with no EGFR or ALK positive tumor mutations. The additional indication brings its EU label into line with that in the US, where it obtained the first-line use approval in October.

It opens up still wider the most important market for the Merck product at a time when its major competitor Bristol-Myers Squibb Co.’s Opdivo (nivolumab) is struggling. Merck is...

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