AstraZeneca Pharma India has received approval to import, sell, and distribute Durvalumab Solution for Infusion (120 mg/2.4 mL and 500 mg/10 mL), branded as Imfinzi, for an additional indication. This approval allows Durvalumab, in combination with specific chemotherapy, to be used for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). The announcement was made on January 31, 2026.
Durvalumab Approval Received
AstraZeneca Pharma India Limited has secured permission to import and market Durvalumab Solution for Infusion. The drug, known under the brand name Imfinzi, is approved in two dosages: 120 mg/2.4 mL and 500 mg/10 mL. This approval marks an extension of the drug’s application to a new therapeutic area.
Treatment of Gastric Cancer
The newly approved indication for Durvalumab includes its use in combination with chemotherapy (specifically, fluorouracil, leucovorin, oxaliplatin, and docetaxel, or FLOT) as neoadjuvant and adjuvant treatment. Following this combined approach, single-agent Durvalumab is indicated for adult patients suffering from resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Marketing and Availability
The approval now clears the path 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. This expansion enhances treatment options for patients battling these specific cancers.
Source: BSE
