The Indian medicine regulator has given the drug company AstraZeneca India permission to market a medication to treat biliary tract cancer (BTC) in the nation, the company announced on Friday. The Central Drugs Standard Control Organization (CDSCO) has given the business permission to market Durvalumab, according to a statement from the pharmaceutical company.
A category of uncommon and aggressive GI tumors known as BTC develop in the cells of the gallbladder, ampulla of Vater, or bile ducts (cholangiocarcinoma) (where the bile duct and pancreatic duct connect to the small intestine). In contrast to ampullary cancer, early-stage BTC frequently manifests without obvious symptoms, and as a result, the majority of new instances of BTC are discovered at an advanced stage when the prognosis is dismal and the treatment choices are few.
Every year, India sees more than 30,000 new cases of BTC, 90% of which are identified at an advanced stage. Sanjeev Panchal, MD and Country President of AstraZeneca India, said that the approval “underpins our commitment to enhance patient outcomes by harnessing the power of science while tackling high unmet need.”
Chemotherapy was the only option for treatment for the past ten years, and the survival statistics were found to be appalling, according to Anil Kukreja, vice president of medical affairs and regulatory at AstraZeneca India. With this historic approval, immunotherapy-based combo treatments are now the only ones available in the nation that significantly increase survival rates, the author continued.
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