US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical cancer. The NMPA’s decision was based on the positive results from the global Phase III KEYNOTE-A18 study.
Keytruda’s Expanding Indications in China
First approved in China in 2018, Keytruda has since garnered more than 10 indications in the country, demonstrating its versatility in treating various cancers. These indications include melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, triple negative breast cancer, MSI-H/dMMR solid tumor, gastric cancer, and bile duct cancer, among others.
The Impact of Keytruda’s Approval for Cervical Cancer
The addition of cervical cancer to Keytruda’s list of indications in China highlights the drug’s potential in addressing a significant unmet medical need. This approval not only expands the treatment options for patients with advanced stages of cervical cancer but also underscores Merck’s commitment to bringing innovative immunotherapies to patients globally.-Fineline Info & Tech
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