BRIEF—AstraZeneca India gets CDSCO nod for new breast cancer treatment

12 May 2025

The Indian subsidiary of UK pharma major AstraZeneca has announced a Central Drugs Standard Control Organization (CDSCO) approval to import for sale and distribution of trastuzumab deruxtecan concentrate for solution for infusion 100mg for an additional indication, according to a Healthcare Radius report.

The drug is marketed by AstraZeneca and partner Japan’s Daiichi Sankyo under the trade name Enhertu, and generated sales of $1.98 billion for AstraZeneca in 2024.

The medicine is now indicated as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low (IHC 1+ and IHC 2+/ISH-) or HER2- ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in a metastatic setting.

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