AstraZeneca Pharma India gets CDSCO nod for Datopotamab deruxtecan for treating metastatic breast cancer

CAR-T Digest - August 2020

18 December 2025: AstraZeneca Pharma India gets CDSCO nod for Datopotamab deruxtecan for treating metastatic breast cancer

AstraZeneca Pharma India Ltd. announced that the Central Drugs Standard Control Organisation (CDSCO) has granted approval to import, sell, and distribute datopotamab deruxtecan (Dato-DXd) in India, reinforcing the company’s commitment to rapidly bringing innovative, life-changing oncology medicines to patients
Supported by results from the Phase 3 TROPION-Breast01 trial, Dato-DXd demonstrated a 37% reduction in the risk of disease progression or death versus standard chemotherapy, with consistent progression-free survival benefit across subgroups and a manageable safety profile, positioning it as a promising new treatment option for patients with previously treated metastatic disease in India
This milestone marks AstraZeneca’s second antibody–drug conjugate approval in India, following trastuzumab deruxtecan (T-DXd), and further strengthens its expanding oncology portfolio, with details on the local launch timeline to be shared after completion of all remaining regulatory steps
The approval comes at a critical time, as breast cancer is now the most commonly diagnosed cancer globally and the leading cancer among Indian women, with incidence in India rising by nearly 40% over the past 25 years and many patients still presenting at advanced stages with poor outcomes