New Launch3 Oct 2025, 08:41 pm
AstraZeneca Pharma India Ltd Receives Permission for Enhertu's Additional Indication
AI Summary
AstraZeneca Pharma India Limited has been granted permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import and distribute Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) for an additional indication. This approval allows Enhertu to be used for treating adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. The marketing of Enhertu in India for this additional indication is subject to the receipt of related statutory approvals.
Key Highlights
- AstraZeneca Pharma India Ltd has received permission from the Central Drugs Standard Control Organisation for an additional indication of Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu)
- Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options
- The approval allows for the marketing of Enhertu in India for the specified additional indication, subject to the receipt of related statutory approvals