AstraZeneca India gets DCGI nod for Imfinzi in endometrial cancer

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

ASTRAZEN · price

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Nifty Microcap 250market · in no size index; the smallest one is used+1.0%+2.6% vs market

Pharmaceuticals peers, median of 159sector+0.4%+3.2% vs sector

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AI summary

AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Durvalumab (brand name Imfinzi, 120 mg/2.4 mL and 500 mg/10 mL) in India for an additional indication. It is now approved for first-line treatment of adults with primary advanced or recurrent endometrial cancer, in combination with carboplatin and paclitaxel, followed by Durvalumab monotherapy maintenance in mismatch repair deficient (dMMR) cases. Marketing is subject to additional statutory approvals.

Likely market impact

Positive: widens Imfinzi's addressable market in India, potentially boosting future revenue from the oncology portfolio.