AstraZeneca Pharma India has informed that on June 10, 2026, the company has received permission from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India to import for sale and distribution of Trastuzumab deruxtecan 100 mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu®) for an additional indication. Through this approval, Trastuzumab deruxtecan in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer. The receipt of this permission paves way for the marketing of Trastuzumab deruxtecan 100 mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu®) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
The above information is a part of company’s filings submitted to BSE.
