AstraZeneca gets CDSCO approval for drug to treat biliary tract cancer

AstraZeneca India announced that it has received approval from the country's drug regulator to market a drug to treat biliary tract cancer (BTC). Durvalumab has been approved by the Central Drugs Standard Control Organisation (CDSCO), according to a statement from the pharmaceutical company. BTC is a type of gastrointestinal (GI) cancer that develops in the cells of the bile ducts (cholangiocarcinoma), gallbladder, or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).

Aside from ampullary cancer, early-stage BTC frequently presents with no clear symptoms, and the majority of new cases of BTC are thus diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor. Every year, over 30,000 new cases of BTC are diagnosed in India, with 90% of them being in an advanced stage. "The approval validates our commitment to transform patient outcomes by leveraging the power of science while addressing high unmet need," said Sanjeev Panchal, MD and Country President of AstraZeneca India.

Chemotherapy was the only option for treatment for the last decade, and survival rates were found to be dismal, according to Anil Kukreja, Vice President Medical Affairs and Regulatory at AstraZeneca India. "With this milestone approval, the country now has the only immunotherapy-based combination treatment option that offers significantly improved survival rates," he added.