INDIA – AstraZeneca India has received the go-ahead from Central Drugs Standard Control Organization (CDSCO) to market its drug Durvalumab for biliary tract cancer (BTC) treatment in India.

The science-led biopharmaceutical company pointed out that its novel drug for treating biliary tract cancer will be available in solution forms in strengths of 120 mg/ 2.4 ml and 500 mg/ 10 ml.

BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts, gallbladder, or ampulla of Vater.

Many cases of BTC are diagnosed at an advanced stage when treatment options are limited, and the prognosis is poor.

Over the last decade, chemotherapy was the only choice of treatment for biliary tract cancer and the survival rates were found to be dismal.

AstraZeneca presents a unique treatment option for Indian patients at a time when more than 30,000 new cases of BTCs are reported in the country annually.

Following additional indication approval from CDSCO, AstraZeneca’s Durvalumab will be used in combination with chemotherapy in locally advanced or metastatic BTC.

 “Durvalumab is already approved for use in Stage-III locally advanced, unresectable Non-Small Cell Lung Cancer (NSCLC) post chemoradiotherapy as maintenance treatment and as 1st line treatment in combination with chemotherapy in Extensive-Stage Small Cell Lung Cancer (ES-SCLC),” the company announced in a statement.

AstraZeneca’s BTC treatment is the only immunotherapy-based combination treatment option in India offering significantly improved survival rates.

The approval for the 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.

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 of Medical Affairs and Regulatory at AstraZeneca India.

He underscored that the CDSCO approval reiterates the company’s commitment to transforming patient outcomes and tackling unmet healthcare needs by harnessing the power of science.

Being patient-centric, we are committed to helping people with chronic diseases live better and healthier lives,” added Dr. Panchal.

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