Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that its drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced or metastatic biliary carcinoma (BTC) in combination with chemotherapies. This marks the 13th indication approval for Keytruda in the China market.
The approval is supported by the positive results of the global Phase III KEYNOTE-966 study, which demonstrated the efficacy and safety of Keytruda in combination with chemotherapy for patients with BTC. Since its initial approval in China in July 2018, Keytruda has been approved for a range of indications, including melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal carcinoma (CRC), gastric cancer, hepatocellular carcinoma, breast cancer, and gastric or gastroesophageal junction adenocarcinoma.
The expansion of Keytruda’s indication to include BTC underscores MSD’s commitment to addressing significant unmet medical needs and providing patients with advanced cancer options for improved treatment outcomes.- Flcube.com
