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Pembrolizumab Granted 5 Additional Approvals in Japan

Gina Columbus @ginacolumbusonc
Published: Thursday, Jan 03, 2019

Dr. Roy Baynes

Roy Baynes, MD, PhD
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has approved pembrolizumab (Keytruda) for 5 new indications, including melanoma, advanced microsatellite instability-high (MSI-H) tumors, and 3 expanded uses in advanced non–small cell lung cancer (NSCLC).1

“These 5 simultaneous approvals of Keytruda in Japan represent a significant achievement that involved extensive collaboration with the Japan Pharmaceuticals and Medical Devices Agency,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We appreciate the agency’s efforts to expedite availability of this important medicine to more patients living with cancer in Japan.”

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