Merck Reports Approval In Japan For KEYTRUDA Regimen For Certain Patients With NSCLC

(RTTNews) - Merck (MRK) announced the Japanese Ministry of Health, Labor and Welfare has approved new indications for KEYTRUDA or pembrolizumab, the company's anti-PD-1 therapy, in certain lung and urothelial cancers. The approval of KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment for patients with NSCLC was based on results from the Phase 3 KEYNOTE-671 trial. The approval of KEYTRUDA in combination with enfortumab vedotin for the first-line treatment of patients with radically unresectable urothelial carcinoma was based on results from the first interim analysis of the Phase 3 KEYNOTE-A39 trial. The approval of KEYTRUDA as monotherapy for patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy was based on results from the phase 2 KEYNOTE-052 trial.

Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said: "With these new approvals, we look forward to providing KEYTRUDA as monotherapy and in combination with other treatment regimens as we aim to address the unmet needs of these patients."

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