British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca PLC’s India arm announced that it received additional indication approval from the Central Drugs Standard Control Organization (CDSCO) for the drug Durvalumab to treat biliary tract cancer (BTC) in India.
BTC is a group of rare and aggressive gastrointestinal cancers that form in the cells of the bile ducts, gallbladder, or ampulla of Vater which is the small opening that leads into the first portion of the small intestine, known as the duodenum.
Early-stage BTC often presents without clear symptoms, and so most new cases of BTC are diagnosed at an advanced stage, when treatment options are limited, and the prognosis is poor.
Dr. Anil Kukreja, vice-president, Medical Affairs and Regulatory, AstraZeneca India, said, “For the last decade, chemotherapy was the only choice of treatment and the survival rates were found to be dismal. This milestone approval now becomes the only immunotherapy-based combination treatment option in the country that offers significantly improved survival rates. Going ahead, we will continue our research to extend the benefits of advanced treatment options for patients suffering from different types of GI cancers.”
The current approval for the molecule is for its use in combination with chemotherapy in locally advanced or metastatic BTC.
Last updated: December 26th, 2025
