AstraZeneca Secures CDSCO Nod for Cancer Drug Durvalumab in India

AstraZeneca Pharma India Ltd has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute the cancer treatment drug Durvalumab in India. This approval allows for the marketing of Durvalumab, combined with Tremelimumab, for treating unresectable hepatocellular carcinoma.

AstraZeneca Pharma India Ltd announced on Monday that it has been granted approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute the cancer treatment medication Durvalumab across India.

This authorization, provided by the Directorate General of Health Services, Government of India, relates specifically to the import, sale, and distribution of the Durvalumab solution for infusion, available in 120 mg/2.4 ml and 500 mg/10 ml formulations, branded as Imfinzi. The approval is for a new indication.

According to a regulatory filing by the company, Durvalumab, when used in combination with Tremelimumab, is intended for the treatment of patients with unresectable hepatocellular carcinoma (uHCC). This regulatory green light will allow for the marketing of the drug in the specified dosages within India, pending further statutory approvals.

(With inputs from agencies.)