AstraZeneca Pharma India Receives Approval for Datopotamab Deruxtecan in India
AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India to import and distribute Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) (Brand name: Datverzo). This new drug 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 marketing of Datverzo in India is subject to the receipt of related statutory approvals.
Key Highlights
- AstraZeneca Pharma India Ltd has received permission to import and distribute Datopotamab Deruxtecan in India.
- Datopotamab Deruxtecan is indicated for the treatment of unresectable or metastatic, HR-positive, HER2-negative breast cancer.
- The new drug is for patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
- The marketing of Datverzo in India is subject to the receipt of related statutory approvals.
- This is a significant step for AstraZeneca Pharma India in the field of oncology.