AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication.
Through this approval, Durvalumab is indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
The receipt of this permission paves way for the marketing of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
The USFDA has already approved durvalumab (Imfinzi) for treating several types of cancer; In June 2024, it was approved for mismatch repair deficient endometrial cancer and in Aug 2024 it was approved for Resectable non-small cell lung cancer. Followed by, in December 2024, it was approved for limited-stage small cell lung cancer for adults whose disease has not progressed after chemotherapy and radiation therapy
