FDA approves trastuzumab deruxtecan (T-DXd) plus pertuzumab for first-line treatment of HER2-positive metastatic breast cancer.
The approval is supported by randomized phase 3 data demonstrating a significant improvement in progression-free survival compared with taxane-based regimens, with deeper and more durable
responses observed in the investigational arm. These results support earlier use of an antibody-drug conjugate–based, chemotherapy-free strategy and represent a meaningful shift in the frontline HER2-positive treatment paradigm.
Key clinical considerations include appropriate patient selection and proactive monitoring for known toxicities, including interstitial lung disease.