AstraZeneca Gets CDSCO Approval For Cancer Treatment Drug Durvalumab

The approval for AstraZeneca molecule is based on the findings of TOPAZ-1, a phase-3 global clinical trial with patients recruited from India as well, that evaluated immunotherapy plus chemotherapy as first line treatment for advanced BTCs, the company said.

In India, more than 30,000 new cases of BTCs are reported every year with 90% of them diagnosed in the advanced stage. In fact, statistics show a high incidence of gall bladder cancer in the northern part of India.

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 are therefore diagnosed at an advanced stage, when treatment options are limited, and the prognosis is poor.

“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", said Dr. Anil Kukreja, vice-president, Medical Affairs and Regulatory, AstraZeneca India.

“The approval underpins our commitment to transform patient outcomes by harnessing the power of science while addressing high unmet need. Being patient centric, we are committed to help people with chronic diseases live better and healthier lives", said Dr Sanjeev Panchal, MD and Country President AstraZeneca India.