AstraZeneca Pharma India Receives CDSCO Approval for Imfinzi Cancer Treatment
AstraZeneca Pharma India Limited has obtained CDSCO permission to import and distribute Durvalumab Solution for Infusion (Imfinzi) in 120 mg/2.4 mL and 500 mg/10 mL formulations for treating advanced endometrial cancer. The approved protocol involves combination therapy with carboplatin and paclitaxel, followed by Durvalumab monotherapy maintenance treatment for mismatch repair deficient endometrial cancer. This regulatory clearance enables marketing of the cancer treatment in India for the additional indication, subject to any remaining statutory approvals.
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AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Durvalumab Solution for Infusion under the brand name Imfinzi for an additional therapeutic indication. The company announced this development through a regulatory filing dated February 10, 2026.
Regulatory Approval Details
The CDSCO, under the Directorate General of Health Services, Government of India, has granted permission for two formulations of the cancer treatment drug:
| Parameter: | Details |
|---|---|
| Drug Name: | Durvalumab Solution for Infusion (Imfinzi) |
| Formulations: | 120 mg/2.4 mL and 500 mg/10 mL |
| Regulatory Body: | Central Drugs Standard Control Organisation |
| Approval Type: | Import for sale and distribution |
| Indication: | Additional therapeutic use |
Treatment Protocol and Indication
The approved treatment protocol involves a combination therapy approach for endometrial cancer patients. Durvalumab will be used in combination with carboplatin and paclitaxel as first-line treatment for adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
Following the initial combination treatment, patients will receive maintenance treatment with Durvalumab as monotherapy, specifically for endometrial cancer that is mismatch repair deficient (dMMR). This targeted approach addresses a specific subset of endometrial cancer cases with particular genetic characteristics.
Market Access and Next Steps
The regulatory approval paves the way for AstraZeneca Pharma India to market Imfinzi in India for the specified additional indication. However, the company noted that marketing activities remain subject to obtaining any related statutory approvals that may be required.
This approval expands the therapeutic applications of Imfinzi in the Indian market, potentially providing new treatment options for patients with advanced endometrial cancer. The drug's availability will depend on the completion of any remaining regulatory requirements and the company's commercial launch timeline.
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