AstraZeneca India Secures CDSCO Nod to Launch Datverzo for Advanced Breast Cancer

Updated: December 17, 2025 23:58

Image Source: Medical Dialogues

AstraZeneca Pharma India has received CDSCO approval to import, market, and distribute Datverzo (Datopotamab Deruxtecan) for adult patients with advanced HR+/HER2-negative breast cancer previously treated with endocrine therapy and chemotherapy. This approval marks a significant advancement in India’s oncology care, offering a new targeted therapy option for those with limited treatment choices.

AstraZeneca Pharma India has received CDSCO approval to import, market, and distribute Datverzo (Datopotamab Deruxtecan) for adult patients with advanced HR+/HER2-negative breast cancer previously treated with endocrine therapy and chemotherapy. This marks a major step forward in India’s oncology treatment landscape.

AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, to import for sale and distribution Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin), branded as Datverzo. This new drug is specifically indicated for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative breast cancer who have already undergone prior endocrine-based therapy and chemotherapy for their disease.

The approval paves the way for Datverzo’s marketing in India for this targeted indication, pending any additional statutory requirements. Datopotamab Deruxtecan is an antibody-drug conjugate developed to address a critical unmet need in advanced breast cancer therapy, offering a new treatment pathway for patients with limited options.

Key Highlights:

Datverzo (Datopotamab Deruxtecan) is approved for HR+/HER2-negative metastatic breast cancer in adults previously treated with endocrine therapy and chemotherapy.
The CDSCO nod enables AstraZeneca to import and market Datverzo in India, pending final regulatory clearances.
Datopotamab Deruxtecan is a novel antibody-drug conjugate, representing a significant advancement in targeted breast cancer therapy.
Patients eligible for this therapy must have unresectable or metastatic disease and have received prior systemic treatments.
The approval underscores India’s expanding access to innovative oncology drugs and precision medicine.

Source: Central Drugs Standard Control Organization (CDSCO), AstraZeneca Pharma India, Business Standard, Express Pharma, Medical Dialogues.

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