FDA Approves Expanded Use of Tukysa for HER2-Positive Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved tucatinib (Tukysa), in combination with trastuzumab and pertuzumab, for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer. This expanded indication applies to patients who have not experienced disease progression following initial induction therapy. The approval was supported by results from the HER2CLIMB-05 trial, which showed a significant reduction in the risk of disease progression or death with the tucatinib combination.