AstraZeneca Pharma India Limited has submitted a regulatory disclosure to BSE Limited and National Stock Exchange of India Limited under SEBI Listing Regulation 30.
The company received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India on July 27, 2026. The approval allows for the import for sale and distribution of Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion, marketed under the brand name Enhertu®, for an additional indication.
The newly approved indication is for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, specifically using Trastuzumab deruxtecan followed by a taxane, trastuzumab, and pertuzumab (THP) treatment regimen.
This approval enables the marketing of Enhertu® in India for this additional indication, though the company notes this is subject to receipt of related statutory approvals, if any.
The disclosure was signed by Tanya Sanish, Company Secretary & Compliance Officer of AstraZeneca Pharma India Limited, on July 28, 2026.