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(10/02/2026 14:35)

AstraZeneca gets CDSCO approval for Imfinzi in additional cancer indication

AstraZeneca Pharma India Ltd on Tuesday said it has received regulatory approval from India’s drug regulator to market its cancer therapy Imfinzi for an additional indication.

The company has been granted permission by the Central Drugs Standard Control Organisation, Directorate General of Health Services, to import, sell, and distribute Durvalumab solution for infusion in strengths of 120 mg/2.4 ml and 500 mg/10 ml under the brand name Imfinzi, for the new indication, according to a regulatory filing.

With this approval, Durvalumab, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are eligible for systemic therapy. This is to be followed by maintenance treatment with Durvalumab as monotherapy in patients with mismatch repair-deficient (dMMR) endometrial cancer.

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