and ‘s ENHERTU has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the treatment of a specific type of metastatic breast cancer. ENHERTU is intended for patients with unresectable or metastatic hormone receptor-positive HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC >0 <1+) breast cancer. The gold standard of business intelligence.
Eligible patients should have received two previous lines of endocrine therapy in the metastatic setting, or a single line of endocrine therapy if they showed disease progression within six months of beginning first-line treatment with endocrine therapy along with a CDK4/6 inhibitor or within 24 months of the commencement of adjuvant endocrine therapy. An antibody-drug conjugate, ENHERTU is developed by Daiichi Sankyo and co-commercialised with AstraZeneca. It targets HER2, a protein associated with aggressive breast cancer.
The FDA granted the designation based on preliminary results from the global, randomised, open-label Phase III DESTINY-Breast06 trial. It compared the efficacy and safety of ENHERTU against standard chemotherapies. Access the most comprehensive Company Profiles on the market, powered by GlobalData.
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