US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have experienced disease progression after previous treatment with fluorouracil, oxaliplatin, and irinotecan, as well as other solid tumors that have progressed without satisfactory alternative treatment options. This marks the PD-1 inhibitor’s 11th indication approval in China and its first based on specific biomarker status rather than tumor type.
Global Study Results Support Approval
The approval of pembrolizumab, the world’s first immunotherapy to treat advanced solid tumors based on MSI-H/dMMR status, is backed by the results of the global Phase II KEYNOTE-158 and KEYNOTE-164 studies. Since its first approval in China in July 2018, Keytruda has garnered approvals covering a range of cancers, including melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal carcinoma (CRC), gastric cancer, hepatocellular carcinoma, and breast cancer. In 2021, the drug earned market approval in the country to treat first-line MSI-H/dMMR CRC.
Expanding Treatment Options for Chinese Patients
The latest approval expands the treatment options for Chinese patients with MSI-H/dMMR advanced solid tumors, offering a biomarker-driven approach to immunotherapy. This milestone underscores Merck’s commitment to advancing cancer treatments and addressing unmet medical needs in China.-Fineline Info & Tech
