AstraZeneca India Receives CDSCO Approval for Datopotamab Deruxtecan in HR-Positive, HER2-Negative Breast Cancer
核心洞察
AstraZeneca Pharma India Limited has received permission from India's Central Drugs Standard Control Organization (搜索) to import and distribute Datopotamab Deruxtecan powder for infusion.
The approval covers treatment of adult patients with unresectable or metastatic, hormone receptor (搜索)-positive, HER2 (搜索)-negative breast cancer who have received prior endocrine therapy and chemotherapy.
This regulatory milestone enables marketing of the 100 mg powder for concentrate formulation under the brand name Datverzo (搜索) in India for the specified indication.
AstraZeneca Pharma India Limited has secured regulatory approval from India's Central Drugs Standard Control Organization (搜索) (CDSCO (搜索)) to import and distribute Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg, marking the entry of this antibody-drug conjugate into the Indian market under the brand name Datverzo (搜索).
Regulatory Approval Details
The CDSCO (搜索), operating under the Directorate General of Health Services of the Government of India, has granted permission for the import, sale, and distribution of this recombinant DNA-origin therapeutic. This approval represents the drug's classification as a new drug in India, requiring specific regulatory clearance for market entry.
Therapeutic Indication
The approved indication covers treatment of adult patients with unresectable or metastatic, hormone receptor (搜索) (HR)-positive, human epidermal growth factor receptor 2 (搜索) (HER2 (搜索))-negative breast cancer. Specifically, the therapy is indicated for patients whose tumors are characterized as IHC 0, IHC 1+, or IHC 2+/ISH-negative for HER2 expression.
The approval applies to patients who have previously received endocrine-based therapy and chemotherapy for their unresectable or metastatic disease, positioning Datopotamab Deruxtecan as a treatment option for this pre-treated patient population.
Market Access Pathway
The regulatory permission establishes the foundation for marketing Datopotamab Deruxtecan in India for the specified breast cancer indication. However, the company notes that actual market launch remains subject to obtaining any additional statutory approvals that may be required.
This approval expands access to Datopotamab Deruxtecan for Indian patients with this specific breast cancer subtype, following the established regulatory pathway for new drug introductions in the country's pharmaceutical market.