AstraZeneca Pharma India Ltd Receives Permission for Additional Indication of Durvalumab Solution for Infusion

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 [Brand Name: Imfinzi] for an additional indication. The new indication is for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). The treatment will be in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single-agent Durvalumab. This approval paves the 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.