FDA Okays First Targeted Agent for HER2-Low Breast Cancer

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FDA Okays First Targeted Agent for HER2-Low Breast Cancer
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The FDA has approved trastuzumab deruxtecan for HER2-low breast cancer. BCSM FDAapproves

AstraZeneca's IV infusion is the first therapy approved for HER2-low breast cancer, a newly defined subset of HER2-negative breast cancer in which there are some HER2 proteins on the cell surface, but not enough to warrant classification as HER2-positive cancer, the agency said in aThe indication is for patients who have received prior chemotherapy in the metastatic setting or for patients whose cancer has returned during adjuvant chemotherapy or within 6 months of completing it.

Of these patients, 373 were randomly assigned to received trastuzumab deruxtecan every 3 weeks, and 184 were randomly assigned to receive physician's choice of chemotherapy (eribulin,

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