Merck’s KEYTRUDA ® (pembrolizumab) Receives Five New Approvals in Japan, Including in Advanced Non-Small Cell Lung Cancer (NSCLC), as Adjuvant Therapy for Melanoma, and in Advanced Microsatellite Instability-High (MSI-H) Tumors

Source: Business Wire, January 2019

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that KEYTRUDA, Merck’s anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA), including three expanded uses in advanced non-small lung cancer (NSCLC), one in melanoma, as well as a new indication in advanced microsatellite instability-high (MSI-H) tumors. The following new approvals were all granted priority review by the PMDA:

• KEYTRUDA in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-189);
• KEYTRUDA in combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of unresectable, advanced/recurrent squamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-407);