AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import and market Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL, sold under the brand name Imfinzi, for an additional indication in India.
With this approval, Durvalumab in combination with carboplatin and paclitaxel can now be used as a first-line treatment for adult patients with primary advanced or recurrent endometrial cancer who are suitable for systemic therapy. After combination therapy, the treatment will be followed by maintenance therapy with Durvalumab alone in patients whose cancer is mismatch repair deficient (dMMR).
This permission clears the way for AstraZeneca to market Imfinzi for this new indication in India, subject to related statutory approvals, if required.
In addition, the Subject Expert Committee (SEC) on Oncology, during its 03nd/26 meeting held on 28 January 2026 at CDSCO Headquarters, New Delhi, reviewed another proposal related to Durvalumab. The committee considered the firm’s application to conduct a Phase IV clinical trial titled “A Phase IV, prospective, multi-centre, single-arm safety study to assess the safety and tolerability of perioperative Durvalumab in combination with neoadjuvant gemcitabine plus cisplatin in Indian patients with muscle-invasive bladder cancer”.
After detailed discussion, the committee recommended granting permission to conduct the Phase IV study as per the presented protocol, with certain conditions. These include that all Principal Investigators must be Medical Oncologists, day care facilities must not be used as clinical trial sites, and the clinical trial sites should be geographically distributed across the country.
