Japan Keytruda NSCLC Approval Sets Stage For Opdivo Showdown

Keytruda has been approved in Japan for lung cancer, including first-line use, in a batch of new regulatory clearances that also include the country's first prescription drug for irritable bowel syndrome with constipation.

Approved

Merck Sharp & Dohme Ltd.'s (Merck & Co. Inc.) Keytruda (pembrolizumab) has received approval in Japan for the additional major indication of non-small cell lung cancer (NSCLC), and looks likely to reach the market in the first few months of next year after it receives a reimbursement price.

The PD-1-targeting antibody is indicated for PD-L1-positive unresectable advanced/recurrent NSCLC in both the first- and second-line treatment settings, and is...

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