Merck's PD-1 Inhibitor Keytruda Approved in China with New 400mg Every Six Weeks Dosing Regimen

SHANGHAI, March 17, 2021 /PRNewswire/ -- MSD (MSD is the trade name of Merck & Co., Inc., Kenilworth, New Jersey, USA) announced that its PD-1 inhibitor pembrolizumab (brand name: KEYTRUDA®) has received approval from the National Medical Products Administration (NMPA) of China for an additional dosing regimen of 400 mg every six weeks (Q6W).

Dr. Li Zhengqing, Senior Vice President and President of MSD’s China R&D Center, stated, “MSD remains committed to advancing scientific exploration to deliver innovative therapeutic and medication solutions for patients and healthcare professionals. We are honored that the 400 mg every-six-weeks dosing regimen for pembrolizumab has received expedited approval from China’s National Medical Products Administration for all its indications in the country. This new dosing option will help reduce the frequency of treatment administration for patients and enhance physicians’ flexibility in designing treatment plans.”

Following this approval, the recommended dosage of pembrolizumab for adults in China is 200 mg every 3 weeks or 400 mg every 6 weeks, applicable to all currently approved indications:

Joseph Romanelli, Global Senior Vice President and President of MSD China, stated, “In China, many cancer patients seek treatment at large or comprehensive hospitals. The approval of the 400 mg dose of pembrolizumab administered every six weeks provides physicians with a new option to ensure greater flexibility in patient medication management, thereby better meeting patients’ therapeutic needs. This is particularly important during the normalized phase of epidemic prevention and control, and fully demonstrates MSD’s steadfast commitment and unremitting efforts to benefit more patients in China.”

[1] Prior to this approval, the recommended dose for this indication was 2 mg/kg once every 3 weeks.