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In addition, FDA said the patient brochure is misleading because it fails to disclose information regarding the serious risks associated with Alymsys

Cancer Res 18 , 11531165 (2020)

Methods Adults with previously untreated, high-risk HER2-positive eBC (T3 or node-positive [N13], including inflammatory disease) were randomized 1:1:1 to: T-DXd-THP: T-DXd 5.4 mg/kg every 3 weeks 4 cycles THP 4 cycles (n=321) ddAC-THP: Doxorubicin + cyclophosphamide every 2 weeks 4 cycles THP 4 cycles (n=320) T-DXd alone: 5.4 mg/kg every 3 weeks 8 cycles (n=286) The primary endpoint was pathologic complete response (pCR