FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...
