The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Durvalumab, the drug firm said in a statement.
BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form 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).
Apart from ampullary cancer, early-stage BTC often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited, and the prognosis is poor.
More than 30,000 new cases of BTC are seen in India every year with 90 per cent of them diagnosed in the advanced stage.
“The approval underpins our commitment to transform patient outcomes by harnessing the power of science while addressing high unmet need,” AstraZeneca India MD and Country President Sanjeev Panchal said.
For the last decade, chemotherapy was the only choice of treatment and the survival rates were found to be dismal, AstraZeneca India Vice-President Medical Affairs and Regulatory Anil Kukreja noted. “This milestone approval now becomes the only immunotherapy-based combination treatment option in the country that offers significantly improved survival rates,” he added.