Tatiana Prowell, Cross-Center Team Leader, Medical Oncology Review (MORE CCTL) at FDA, shared on X:
“Today FDA approved maintenance tucatinib with trastuzumab/pertuzumab for adults with HER2 positive advanced Metastatic Breast Cancer after induction based on HER2CLIMB-05 (PFS HR 0.64, mPFS ~25 vs 16 mos; OS ).: hepatotoxicity, diarrhea.
For a concise summary of HER2CLIMB-05 trial results and key info about this approval (and malignant Hematology/Oncology regulatory approvals in general) as well as a link to most recent label, Google FDA Oncology approvals or bookmark/share this: Oncology (Cancer)/Hematologic Malignancies Approval Notifications.”
Other articles about breast cancer on OncoDaily.