AstraZeneca Pharma India Receives Permission for Imfinzi's Additional Indication

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 Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). The receipt of this permission allows for the marketing of Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.