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FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
On May 15, 2026, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of adults with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test, followed by taxane, trastuzumab, and pertuzumab (THP). The second indication is for the treatment of adults with HER2-positive (IHC3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.
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