Merck's PD-1 Inhibitor Pembrolizumab Granted New NMPA Approval for MSI-H/dMMR Advanced Solid Tumors in China

Intelligent Finance APP learned on September 8 that the latest approval from the National Medical Products Administration (NMPA) showed that MSD's (MRK.US) PD-1 Pembrolizumab was approved for a new indication. According to official information from MSD, the approved indication this time is for adult patients with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors, including colorectal cancer patients whose disease progressed after prior treatment with fluorouracil, oxaliplatin, and irinotecan, as well as other solid tumor patients whose disease progressed after prior treatment and have no satisfactory alternative treatment options. The approval of this new indication is based on data from the global Phase II clinical trials KEYNOTE-158 and KEYNOTE-164.