Date: June 11, 2026
Regulatory Approval Disclosure
On June 10, 2026, AstraZeneca Pharma India Limited received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India for import, 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.
Product and Indication Details
The approval covers Trastuzumab deruxtecan in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer.
Commercial Implications
This permission enables 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 receipt of related statutory approvals, if any.
Compliance Officer
Tanya Sanish, Company Secretary & Compliance Officer, signed and submitted the disclosure.
Not Specified Sections
No material disclosures under the following sections: KMP / Board / Auditor Changes, Dividend Declaration, Board Meeting Outcomes, Financial Results, Auditor's Report, Disinvestment / Strategic Actions, Media Release / Investor Communication, Other Operational / Legal / Strategic Disclosures.