AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India to import for sale and distribution of Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) for an additional indication.
Through this approval, Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion 100 mg (ENHERTU) is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant Trastuzumab (with or without Pertuzumab) and taxane-based treatment.
The receipt of this permission paves way for the marketing of Trastuzumab Deruxtecan 100mg/5mL 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.
AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.
