US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Wednesday that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved new indications for KEYTRUDA (pembrolizumab) in non-small cell lung carcinoma (NSCLC) and urothelial carcinoma.
KEYTRUDA, in combination with chemotherapy, followed by monotherapy, was approved for NSCLC based on results from the Phase 3 KEYNOTE-671 trial.
For urothelial carcinoma, KEYTRUDA was approved in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment and as monotherapy for patients ineligible for platinum-containing chemotherapy. These approvals are based on results from the Phase 3 KEYNOTE-A39 and Phase 2 KEYNOTE-052 trials, respectively.
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