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Today, FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, a newly defined subset of HER2-negative breast cancer. This is the first drug approved to treat this subtype. thread 1/3
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fda.gov/news-events/pr…
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fda.gov/news-events/pr…
About 80-85% of breast cancer diagnosed annually in the US were considered HER2-negative (including HR+ and triple negative breast cancer). Now, about 60% of patients previously considered HER2-negative can be considered HER2-low (IHC 1+ or IHC 2+/ISH‑) 🧵 2/3
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Efficacy was based on DESTINYBreast04, a randomized clinical trial enrolling 557 patients with unresectable or metastatic HER2-low breast cancer. FDA approved this application about 4 months ahead of the PDUFA date.
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