AstraZeneca's India Arm Receives Nod For Imfinzi Indication To Treat Endometrial Cancer

AstraZeneca Pharma India Limited on Tuesday, July 1, 2025, received approval from the Central Drugs Standard Control Organisation (CDSCO) to import durvalumab solution for infusion (Brand name: Imfinzi) in 120 mg/2.4 ml and 500 mg/10 ml strengths for an additional indication.

In an BSE Sensex exchange filing, the pharma major said, "It has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) for an additional indication."

"Through 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 candidates for systemic therapy, followed by maintenance treatment with Durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR)," it said.

"The receipt of this permission paves way for the marketing of Durvalumab Solution for Infusion 120  mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) in India for the specified additional indication,subject to the receipt of related statutory approvals, if any," it added.

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AstraZeneca Pharma Q4 FY25 Results

AstraZeneca Pharma India report a sharp 47.7 per cent year-on-year (YoY) surge in net profit to Rs 58.2 crore for the fourth quarter ended March 2025, up from Rs 39.4 crore a year earlier.

Revenue for the quarter rose 25.4 per cent to Rs 480.4 crore, compared with Rs 383.2 crore in the same period last year, driven by continued demand across its key therapy areas and improved market penetration.

Earnings before interest, tax, depreciation and amortisation (EBITDA) surged 74.7 per cent to Rs 86.3 crore from Rs 49.4 crore a year ago, reflecting better cost controls and a favourable product mix. The company’s EBITDA margin expanded to 17.96 per cent, up from 12.89 per cent in the corresponding quarter last year.

The management attributed the strong financial results to continued investment in innovation and its portfolio of newer-generation therapies in the oncology, cardiovascular, and respiratory segments.