India Pharma Outlook Team | Friday, 19 December 2025
AstraZeneca Pharma India Ltd. (AZPIL) has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute datopotamab deruxtecan (Dato-DXd) in India for the treatment of metastatic breast cancer. The approval represents an important regulatory milestone for the company’s oncology portfolio in the Indian market.
The CDSCO authorisation allows the use of Dato-DXd in adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have previously been treated with endocrine therapy and chemotherapy. The approval expands treatment options for a patient group that often faces limited choices after disease progression.
Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate (ADC). It combines a humanised anti-TROP2 IgG1 monoclonal antibody with a topoisomerase I inhibitor payload (DXd), linked through a cleavable linker. The drug is designed to selectively target tumour cells expressing TROP2 while delivering cytotoxic therapy directly to cancer cells.
This approval marks AstraZeneca’s second ADC approval in India, following trastuzumab deruxtecan. The development aligns with the company’s broader focus on strengthening its oncology pipeline and introducing advanced biologics for hard-to-treat cancers. The company stated that details related to the commercial launch timeline will be communicated after completion of procedural requirements.
Breast cancer remains the most commonly diagnosed cancer globally, with more than 2.3 million new cases reported in 2022, according to global health data. In India, breast cancer incidence has increased significantly over the past two decades, with a large proportion of patients diagnosed at advanced or metastatic stages, leading to higher mortality rates.
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AstraZeneca cited data from the TROPION-Breast01 clinical trial, which demonstrated improvements in progression-free survival among patients treated with Dato-DXd. The company reiterated its focus on improving access to innovative oncology therapies and supporting evolving treatment standards for breast cancer in India.
