Onco-Summaries: Daily Oncology Updates at a Glance
01/09/2026
Enhertu + pertuzumab secures EU approval as first-line treatment for HER2-positive breast cancer (Ref)
AstraZeneca & Daiichi Sankyo announced that Enhertu (trastuzumab deruxtecan; HER2-directed ADC) in combination with pertuzumab (HER2 dimerization-blocking monoclonal antibody) was approved in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer
Approval was supported by DESTINY-Breast09 Phase III trial, showing a 44% reduction in risk of progression or death vs THP (taxane + trastuzumab + pertuzumab)
Median PFS extended to 40.7 months vs 26.9 months with THP
Safety profile was consistent with known data
Enhertu + pertuzumab has been included in the ESMO Clinical Practice Guidelines as a Category IA 1st-line treatment option for patients with metastatic HER2-positive breast cancer, regardless of hormone receptor (HR) status
Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial
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