AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL, under the brand name Imfinzi. This approval is for an additional indication: Durvalumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single-agent Durvalumab, for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). The receipt of this permission allows for the marketing of Imfinzi in India for this specified additional indication, subject to obtaining any related statutory approvals.
