CDSCO approves Trastuzumab deruxtecan plus Pertuzumab for first-line HER2-positive metastatic Breast cancer

CAR-T Digest - August 2020

Weekly Digest - June 2026

11 June 2026: CDSCO approves Trastuzumab deruxtecan plus Pertuzumab for first-line HER2-positive metastatic Breast cancer

AstraZeneca Pharma India has received CDSCO approval for Enhertu in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer, expanding access to a HER2-directed ADC regimen in India
The approval was supported by data from the phase 3 DESTINY-Breast09 trial, where Enhertu plus pertuzumab significantly improved progression-free survival compared with standard THP (taxane, trastuzumab, and pertuzumab), achieving a median progression-free survival of 40.7 months versus 26.9 months, while also demonstrating a confirmed objective response rate of 87% and disease control in more than 95% of treated patients
The decision enables the use of Enhertu earlier in the treatment pathway for HER2-positive metastatic breast cancer patients in India, further broadening the clinical footprint of the ADC beyond its previously approved later-line indications
Enhertu is a HER2-directed DXd antibody-drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo, combining a HER2 monoclonal antibody with a cleavable linker and a potent topoisomerase I inhibitor payload (DXd), designed to deliver targeted cytotoxicity along with a bystander killing effect in heterogeneous tumors
Strategically, the approval strengthens AstraZeneca’s leadership in HER2-positive breast cancer by moving Enhertu into the first-line metastatic setting in India, reinforcing the company’s ADC-driven oncology strategy while expanding the addressable patient population and increasing competition across the HER2 treatment landscape