AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) for an additional indication.

Through this approval, Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion 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 receipt of this permission paves way for the marketing of Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.