Drugmaker AstraZeneca India has received regulatory approval on an additional indication for Durvalumab to treat biliary tract cancer (BTC) in India.

Announcing the approval from the Central Drugs Standard Control Organization (CDSCO), the company said, BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form, for instance, in the cells of the bile ducts or gallbladder. More than 30,000 new cases of BTCs are seen in India every year with 90 per cent of them diagnosed in the advanced stage, the company said.

In the last decade, chemotherapy has been the only choice of treatment and the survival rates were found to be dismal, the statement said, adding that the latest approval makes the drug the only immunotherapy-based combination treatment option in the country that offers improved survival rates. The company did not divulge the price of the product, but industry data pegs the price at ₹45,000-1.89 lakh for two available variants.

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 first line treatment in combination with chemotherapy in Extensive-Stage Small Cell Lung Cancer (ES-SCLC). In July 2022, Durvalumab plus chemotherapy was added to the National Comprehensive Cancer Network‘s (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 preferred regimen as first-line therapy for locally advanced or metastatic BTC, the company said.