Enhertu recommended for approval in the EU by CHMP for patients with HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy

CAR-T Digest - August 2020

Weekly Digest - March 2025

28 Feb 2025: Enhertu recommended for approval in the EU by CHMP for patients with HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy

Enhertu has been recommended for EU approval as a monotherapy for unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow breast cancer after endocrine therapy
The CHMP’s decision is based on DESTINY-Breast06 trial data, where Enhertu reduced disease progression or death by 38% and improved median PFS to 13.2 months vs. 8.1 months with chemotherapy
Enhertu is the first HER2-directed ADC to show over one year of PFS in patients with HER2-low or HER2-ultralow metastatic breast cancer post-endocrine therapy
The drug is already approved in the US for a similar indication, with regulatory applications under review in Japan and other countries
The safety profile in DESTINY-Breast06 was consistent with previous trials, with no new safety concerns identified