AstraZeneca Pharma India has secured approval to import and distribute Datopotamab Deruxtecan in India. This new drug is a concentrate for solution for infusion (100 mg r-DNA origin) and will be marketed under the brand name Datverzo. It will be available for sale in India. The approval marks a significant step in expanding treatment options for specific patient populations within the country.
Datopotamab Deruxtecan Approval
AstraZeneca Pharma India Limited has received permission to import and distribute Datopotamab Deruxtecan powder for concentrate for solution for infusion in India. The drug, identified as 100 mg (r-DNA origin), will be marketed under the brand name Datverzo. This approval signifies the introduction of a new drug in the Indian market.
Intended Use
Datopotamab Deruxtecan 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 previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
Looking Ahead
This permission paves the 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.
Source: BSE