AstraZeneca Pharma India Limited has informed the Exchange about General Updates
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AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation (CDSCO) to import and market Durvalumab Solution for Infusion (brand name Imfinzi) in 120 mg/2.4 ml and 500 mg/10 ml strengths for an additional indication. The approval covers Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi alone as adjuvant treatment after radical cystectomy, for adult patients with muscle invasive bladder cancer (MIBC). With this nod, the company can now market Imfinzi in India for this additional indication, subject to any further statutory approvals. The drug was already approved in India for other indications and is one of AstraZeneca's key oncology products globally.
This expands the addressable market for Imfinzi in India by adding a new patient segment (muscle invasive bladder cancer), which could support future revenue growth in the oncology portfolio. It is a positive regulatory development but the company has not disclosed any expected financial impact at this stage.