AstraZeneca’s Trastuzumab deruxtecan therapy receives CDSCO nod to manage HER2- low & ultra-low breast cancer in India

CAR-T Digest - August 2020

08 May 2025: AstraZeneca’s Trastuzumab deruxtecan therapy receives CDSCO nod to manage HER2- low & ultra-low breast cancer in India

AstraZeneca received CDSCO approval in India to import and sell Trastuzumab deruxtecan for treating unresectable or metastatic HER2-low or HER2-ultralow breast cancer in adults after at least one endocrine therapy
The approval is based on results from the DESTINY Breast06 trial, which showed superior progression-free survival over chemotherapy in HR-positive, HER2-low or ultralow breast cancer
Trastuzumab deruxtecan demonstrated a median progression-free survival of 13.2 months compared to 8.1 months with chemotherapy in HER2-low patients, significantly improving clinical outcomes
First introduced in India in 2024, this antibody-drug conjugate is now approved for three indications in breast and gastric cancers, offering expanded treatment options