AstraZeneca's Enhertu recommended for EU approval in metastatic breast cancer
Why we think this is good
The RNS announcement indicates that the CHMP has recommended the approval of AstraZeneca's Enhertu for the treatment of HR-positive, HER2-low or HER2-ultralow metastatic breast cancer. This is a positive development for the company as it expands the potential patient population that can be treated with Enhertu, which is an important part of AstraZeneca's oncology portfolio. The announcement does not contain any negative information or financial impacts, so the overall sentiment is positive.
Key Points
- CHMP has recommended approval of Enhertu in the EU for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer
- Recommendation based on positive results from DESTINY-Breast06 Phase III trial showing Enhertu superior to chemotherapy
- Enhertu already approved in the US for this indication, with regulatory reviews ongoing in other countries
Summary
AstraZeneca's Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting. The recommendation is based on positive results from the DESTINY-Breast06 Phase III trial, which showed Enhertu demonstrated superiority over chemotherapy with a median progression-free survival of more than one year in this patient population. Enhertu is already approved in the US for this indication and regulatory applications are under review in other countries.