ZIehera for breast cancer- pro
Ziihera (zanidatamab-hrii) first received accelerated FDA approval on November 20, 2024, for previously treated HER2-positive biliary tract cancer. I found two small Phase I trials, one with only preliminary results. This is insufficient to support medical necessity for breast cancer.
(https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanidatamab-hrii-previously-treated-unresectable-or-metastatic-her2),
Bedard P.L., Im S-A., Elimova E, et al. 303MO Zanidatamab (Zani) + chemotherapy (Chemo) for patients (Pts) with HER2-expressing metastatic breast cancer (mBC): Final results of a phase I trial. ESMO Open. May 2025. doi: 10.1016/j.esmoop.2025.104875
Zanidatamab Plus Chemo Shows Response in HER2+ and HER2-Low mBC. Docwire News. May 16, 2025. https://www.docwirenews.com/post/zanidatamab-plus-chemo-shows-response-in-her2-and-her2-low-mbc