FDA Expands Tucatinib Approval for HER2-Positive Metastatic Breast Cancer Maintenance

The FDA has approved tucatinib (Tukysa), combined with trastuzumab and pertuzumab, for first-line maintenance treatment of unresectable locally advanced or metastatic HER2-positive breast cancer. This decision expands the drug's use to an earlier stage, offering a new chemotherapy-free option based on improved progression-free survival data from the HER2CLIMB-05 trial. A boxed warning for hepatotoxicity is included in the prescribing information.