Merck & Co.'s Keytruda gains Japanese approval for patients with non-small-cell lung cancer

Merck & Co. said Monday that Japanese regulators approved Keytruda (pembrolizumab) for the treatment of certain patients with PD-L1-positive unresectable advanced/recurrent non-small-cell lung cancer (NSCLC). The anti-PD-1 therapy, which will be promoted with Taiho Pharmaceutical in the country, has been cleared in the first- and second-line treatment settings.

According to Merck, the approval was supported by data from the KEYNOTE-024 and KEYNOTE-010 studies. In the KEYNOTE-024 trial, the results of which were presented in October, Keytruda was associated with significant improvements in progression-free survival and overall survival (OS) versus platinum-base chemotherapy in patients with PD-L1-positive NSCLC. Additionally, in the KEYNOTE-010 trial, the therapy was shown to prolong OS versus chemotherapy in patients with PD-L1-expressing NSCLC.

FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Keytruda was approved by the European Commission in August for use in patients with PD-L1-positive locally advanced or metastatic NSCLC who received at least one prior chemotherapy regimen, with the European Medicines Agency's Committee for Medicinal Products for Human Use adopting a positive opinion on first-line use last week. The therapy was cleared by the FDA for the first-line treatment of patients with NSCLC whose tumours have high PD-L1 expression in October, having been authorised the year before for patients whose disease has progressed after prior treatment.

For related analysis, see Physician Views Poll Results: Merck & Co.'s Keytruda gaining traction in first-line NSCLC say oncologists, and Physician Views Poll Results: Oncologist feedback suggests Keytruda will gain ground on Opdivo in second-line NSCLC market.

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