CDSCO Approves AstraZeneca's Durvalumab for Liver Cancer Therapy

AstraZeneca Pharma India Ltd has received approval from the Central Drugs Standard Control Organisation (CDSCO) to launch and import its cancer treatment Durvalumab (Imfinzi) in India. In a regulatory filing, the company noted that the approval is for infusion solution strengths of 120 mg/2.4 ml and 500 mg/10 ml for a new indication.

Durvalumab, in combination with Tremelimumab, has received approval for patients suffering from unresectable hepatocellular carcinoma (uHCC), a fatal form of liver cancer. With this approval, AstraZeneca is authorized to start marketing the drug in India, subject to further regulatory approvals.

The new indication for Durvalumab has come about due to the rising demand for innovative cancer treatments in India. Hepatocellular carcinoma is among the most prevalent forms of liver cancer worldwide, and emerging immunotherapy drugs like Durvalumab and Tremelimumab offer fresh hope to patients with limited alternatives.

AstraZeneca Pharma India, a branch of AstraZeneca, has established itself as a key player in the pharmaceutical sector, focusing on research-driven treatments for oncology, cardiovascular, renal, and metabolic disorders. The company is focused on obtaining regulatory approvals and expanding drug indications to address India's evolving healthcare requirements.