By Fineline Cube 
US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients with tumor expression of PD-L1 (composite positive score [CPS] ≥ 1), as determined through fully validated testing.
Recent Approval Context
This follows the drug’s approval last month in China for use in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical cancer, further expanding its therapeutic applications in the country.
Keytruda’s Market Presence in China
First approved in China in 2018, Keytruda has since garnered over 10 indication approvals in the country. These indications span a range of cancers, including melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, HNSCC, colorectal cancer, hepatocellular carcinoma, triple negative breast cancer, MSI-H/dMMR solid tumors, gastric cancer, and bile duct cancer. The continued expansion of Keytruda’s indications reflects its significant role in the oncology treatment landscape in China.-Fineline Info & Tech