AstraZeneca gets CDSCO nod for Datopotamab Deruxtecan to treat Metastatic Breast Cancer

New Delhi: AstraZeneca Pharma India Ltd. (AZPIL), a global, science-led biopharmaceutical company, today 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.

This approval marks a significant milestone in AstraZeneca’s journey to deliver next-generation oncology treatments and reaffirms its leadership in precision medicine, bringing innovative science to the patients who need it most.

Breast cancer is now the most diagnosed cancer globally, with over 2.3 million cases recorded in 2022 according to the World Health Organization (WHO). In India, the burden continues to grow rapidly, incidence rates have risen by nearly 40% over the past 25 years, making breast cancer the most prevalent cancer among Indian women. Many patients are diagnosed at an advanced stage, where treatment options remain limited and outcomes often poor.

Dr. Sandeep Arora, Director of Medical Affairs, AstraZeneca Pharma India Limited, 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.

In the TROPION-Breast01 trial, Datopotamab Deruxtecan demonstrated a 37% reduction in the risk of disease progression or death compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52–0.76; p<0.0001). The median progression-free survival was 6.9 months for patients treated with Dato-DXd, versus 4.9 months for those receiving chemotherapy. The safety profile of Dato-DXd remained consistent with previous studies, with no new safety signals identified, reinforcing its potential as a well-tolerated and effective treatment option for patients with advanced breast cancer.

This approval advances AstraZeneca’s ambition to transform cancer care, expanding options for patients with advanced breast cancer and underscoring our commitment to rapid access to innovative medicines. Together with T-DXd, Dato-DXd strengthens AstraZeneca India’s ADC portfolio and supports timely availability of next-generation oncology therapies nationwide.