ENHERTU plus pertuzumab supplemental New Drug Application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer

CAR-T Digest - August 2020

Weekly Digest - October 2025

07 October 2025: ENHERTU plus Pertuzumab supplemental New Drug Application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer

Daiichi Sankyo has submitted a supplemental application in Japan to use ENHERTU with Pertuzumab for HER2-positive breast cancer that cannot be surgically removed or has returned
The application is supported by results from the DESTINY-Breast09 trial, showing that combining ENHERTU with Pertuzumab extended progression-free survival to over three years, significantly better than existing therapies
Current HER2 therapies help, but most patients see their cancer progress within two years despite standard treatments with taxane, trastuzumab, and pertuzumab
Daiichi Sankyo emphasizes that this submission builds on its recent approval of ENHERTU for HER2-low metastatic breast cancer, reflecting the company’s goal to make effective treatments available to more patients across different HER2-positive breast cancer subtypes
A supplemental Biologics License Application for ENHERTU plus pertuzumab based on data from DESTINY-Breast09 was also granted Priority Review in the U.S. under the Real-Time Oncology Review program