AstraZeneca Pharma India Limited has received a no objection for an additional/expanded indication from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India, for Durvalumab (Imfinzi) 120 mg/ 2.4 ml and 500 mg/ 10 ml solution for infusion.

 

Through this approval, Durvalumab (Imfinzi) in combination with chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).

 

The receipt of this permission paves way for the launch of Durvalumab (Imfinzi) solution of 120 mg/2.4 ml and 500 mg/10 ml in India for the specified additional/expanded indication.