AstraZeneca Pharma India Ltd. has received approval from the Central Drugs Standard Control Organisation to import and sell Durvalumab Solution for the treatment of adult patients with muscle invasive bladder cancer.
Durvalumab Solution will be used in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy.
The permission granted by CDSCO allows for the marketing of Durvalumab Solution in India, subject to related statutory approvals.
In addition to the bladder cancer drug, AstraZeneca had previously received approval to import and sell sodium zirconium cyclosilicate powder for oral suspension for treating hyperkalemia in adults.