CDSCO Panel Clears AstraZeneca's Datopotamab for Breast Cancer, Seeks Phase IV Trial
New Delhi: The Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization to AstraZeneca Pharma India Limited for Datopotamab Deruxtecan Powder for Concentrate for Solution for Infusion 100 mg for use in India.
The approval came after deliberations during the SEC Oncology meeting held on 8th July 2025.
AstraZeneca submitted its proposal seeking approval to import and market Datopotamab Deruxtecan 100 mg 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 previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The committee noted that the application was supported by results from a global clinical trial conducted by AstraZeneca, which included participation from the Indian population. The SEC also took into account that Datopotamab Deruxtecan has already received regulatory approvals in multiple countries, including the United States, European Union, Japan, Australia, and Singapore.
After detailed discussions, the committee recommended the grant of marketing authorization for Datopotamab Deruxtecan 100 mg for the specified indication, in accordance with the United States Prescribing Information (USPI).
The SEC also stated that AstraZeneca should conduct a Phase IV clinical trial in India as part of the post-marketing requirements. The company has been instructed to submit the Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing approval.
Datopotamab Deruxtecan is an antibody-drug conjugate developed for the targeted treatment of certain breast cancers.
