Merck's KEYTRUDA Wins New Approvals In Japan for Lung & Bladder Cancer Treatments

Merck, known as MSD outside the U.S. and Canada, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has expanded the approved uses of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, to include specific types of lung and bladder cancer.

For non-small cell lung cancer (NSCLC), KEYTRUDA is now approved as part of a combined treatment approach with chemotherapy before surgery (neoadjuvant) and as a standalone therapy after surgery (adjuvant), based on findings from the Phase 3 KEYNOTE-671 study.

In patients with inoperable urothelial carcinoma, KEYTRUDA can now be used alongside Padcev (enfortumab vedotin-ejfv) as an initial treatment option. This approval follows the positive outcomes of the Phase 3 KEYNOTE-A39 (EV-302) trial, a collaborative study with Pfizer (formerly Seagen) and Astellas.

Additionally, KEYTRUDA is approved as a solo treatment for patients with inoperable urothelial carcinoma who are not fit for platinum-based chemotherapy, drawing from evidence gathered in the Phase 2 KEYNOTE-052 trial.

Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said in a statement, “For certain patients in Japan who are diagnosed with resectable non-small cell lung carcinoma and radically unresectable urothelial carcinoma, there is a need for new, effective treatment options. 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.”