Merck's KEYTRUDA® Expands Market Reach in Japan with New Approvals

Merck & Co., Inc. (NYSE: MRK) has received new approvals in Japan for its anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in non-small cell lung carcinoma (NSCLC) and radically unresectable urothelial carcinoma. These approvals expand the market reach of KEYTRUDA® and strengthen Merck's position in the Japanese oncology landscape.

The Japanese Ministry of Health, Labor and Welfare (MHLW) approved KEYTRUDA® in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment, for patients with NSCLC based on results from the Phase 3 KEYNOTE-671 trial. Additionally, KEYTRUDA® was approved in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically unresectable urothelial carcinoma, and as monotherapy for patients who are not eligible for any platinum-containing chemotherapy based on results from the Phase 3 KEYNOTE-A39 and Phase 2 KEYNOTE-052 trials, respectively.

These new indications for KEYTRUDA® increase its market share in Japan's oncology landscape, particularly in lung and urothelial cancers. The estimated patient population in Japan for these new indications is significant, with approximately 130,000 new cases of lung cancer and around 15,000 new cases of bladder cancer diagnosed each year. This expanded market reach contributes to KEYTRUDA®'s overall market potential in Japan.


The approvals position KEYTRUDA® against competing immunotherapies and other treatments in the Japanese market. KEYTRUDA® has demonstrated superior overall survival and progression-free survival in clinical trials, making it a strong contender in the immuno-oncology space. The new indications further solidify KEYTRUDA®'s role in the treatment of lung and urothelial cancers, potentially driving increased revenue for Merck in Japan.


Looking ahead, Merck continues to invest in clinical research to explore new indications for KEYTRUDA®. Ongoing trials are evaluating KEYTRUDA® in various cancer types, including breast, colorectal, and prostate cancers. As data from these trials become available, Merck may seek additional approvals for KEYTRUDA®, further expanding its market reach and potential revenue streams.