Dato-DXd is a specifically engineered antibody drug conjugate that targets TROP2, a protein frequently overexpressed in breast cancer
AstraZeneca Pharma India announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to import, sell, and distribute Datopotamab Deruxtecan (Dato-DXd) in India. The approval reflects AstraZeneca’s focus on bringing to life-changing medicines at a rapid pace and marks its second antibody–drug conjugate (ADC) approval in India after trastuzumab deruxtecan (T-DXd). Further information on potential launch timeline in India will be shared post all necessary approvals are obtained.
Dato-DXd is a novel, TROP2-directed antibody drug conjugate (ADC) developed 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.
Dr Sandeep Arora, Director of Medical Affairs, AstraZeneca Pharma India, added: “While treatment advances have improved outcomes in HR+ HER2- metastatic breast cancer, disease progression following endocrine and chemotherapy remains a critical challenge. The approval of Datopotamab Deruxtecan, based on the TROPION-Breast01 trial, marks an important step forward, demonstrating a meaningful improvement in progression-free survival with consistent PFS benefit across sub-groups, compared to standard of care chemotherapy. This offers a potential new therapeutic option for patients with previously treated, inoperable or metastatic HR positive/HER2 negative breast cancer.”
Praveen Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited said, “At AstraZeneca, we are leading a bold transformation in oncology, following the science to understand cancer in all its complexity and accelerating the delivery of life-changing medicines. The approval of Datopotamab Deruxtecan offers a much-needed treatment option for patients with HR-positive, HER2-negative metastatic breast cancer, potentially earlier in the treatment journey. As our second ADC in India after T-DXd, it exemplifies how we are working to bring innovative therapies to Indian patients as rapidly as possible, and we remain deeply committed to expanding access to medicines that can make a meaningful difference in patients’ lives across the country.”
Dato-DXd is a specifically engineered antibody drug conjugate that targets TROP2, a protein frequently overexpressed in breast cancer. It combines a humanized anti-TROP2 IgG1 monoclonal antibody with a topoisomerase I inhibitor payload (DXd) via a cleavable linker. This design aims to enhance targeted delivery while minimizing systemic toxicity.
