AstraZeneca Gains Permission to Import Enhertu for Neoadjuvant Breast Cancer Treatment in India
AstraZeneca Pharma India Limited has received authorization from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India, allowing it to import and distribute Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu®) for an additional indication.The permission was granted on July 27, 2026. This approval paves the way for marketing Enhertu® in India for a specific new use case.
Under this authorization, Trastuzumab deruxtecan is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.
The receipt of this vital permission allows AstraZeneca Pharma India Limited to introduce Enhertu® into the Indian market for this specialized additional indication, pending any related statutory approvals.
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