New Launch11 Jun 2026, 10:38 am
AstraZeneca Pharma India Gets CDSCO Approval for Enhertu
AI Summary
AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) to import for sale and distribution of Trastuzumab deruxtecan (Enhertu®) 100 mg/5mL vial for an additional indication. This approval allows for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer when used in combination with pertuzumab. The company can now proceed with marketing Enhertu® in India for this specific indication, pending any further statutory approvals.
Key Highlights
- CDSCO approval received for Enhertu® for an additional indication.
- Enhertu® will be used for first-line treatment of HER2-positive breast cancer.
- Approval facilitates marketing of Enhertu® in India for the new indication.
- Subject to related statutory approvals.
Price Impact
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