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

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.

 

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