AstraZeneca Pharma gets permission for sale, distribution of Datopotamab Deruxtecan powder

18 Dec 2025 Evaluate

AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India to import for sale and distribution of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) (Brand name: Datverzo) which is a new drug in India.

Through this approval, Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) (Brand name: Datverzo) in India for the specified 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.


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