
New Launch8 Aug 2026, 12:00 pm
AstraZeneca India gets approval for Enhertu® for new breast cancer indication
AI Summary
AstraZeneca Pharma India Ltd announced on August 7, 2026, that it has received approval from the Central Drugs Standard Control Organization (CDSCO) to import for sale and distribution of Trastuzumab Deruxtecan (Enhertu®) 100mg/5mL lyophilized powder for concentrate for solution for infusion. This approval is for an additional indication: the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant treatment. This paves the way for the marketing of Enhertu® in India for this specific indication, subject to further statutory approvals.
Key Highlights
- Received CDSCO approval for Enhertu® for an additional indication.
- Indication is for adjuvant treatment of HER2-positive breast cancer.
- Approval allows import for sale and distribution in India.
- Subject to related statutory approvals for marketing.
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