AstraZeneca Pharma gets CDSCO nod to market Enhertu for additional indication

AstraZeneca Pharma India announced that it has received nod from the Central Drugs Standard Control Organization, Directorate General of Health Services, Gov of India, to import Enhertu (Trastuzumab Deruxtecan) for sale and distribution in India.

The approval is for an additional indication of the drug in the treatment of HER2-positive breast cancer.

The approval covers Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion 100 mg (ENHERTU) for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant Trastuzumab, with or without Pertuzumab, and taxane-based treatment.

The regulatory approval paves the way for the marketing of Enhertu in India for the specified additional indication, subject to receipt of related statutory approvals, if any.

AstraZeneca Pharma India reported a 22.95% year-on-year decline in standalone net profit to Rs 44.88 crore for the quarter ended March 2026 (Q4 FY26), compared with Rs 58.25 crore in the corresponding quarter of the previous fiscal. Revenue from operations, however, rose 20.42% year-on-year to Rs 578.61 crore during the quarter, up from Rs 480.48 crore in the year-ago period.

The scrip rose 1.20% to end at Rs 8,188.15 on the BSE.

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