AstraZeneca Pharma India said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute Durvalumab (Imfinzi), medicine to treat patients with unresectable hepatocellular carcinoma (uHCC), a form of liver cancer.
The approval allows the use of Durvalumab in combination with Tremelimumab, broadening treatment options for patients battling advanced-stage liver cancer. While the company still requires other statutory approvals before launching the expanded indication in India, the regulatory green light marks a crucial step in AstraZeneca Pharma’s oncology portfolio expansion.
Shares of AstraZeneca Pharma India rose by as much as 3% on 3 March after the company announced the approval.
The 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, the company said.
