Drugs and FDA
FDA approves tucatinib combination for HER2-positive breast cancer maintenance
The FDA approved tucatinib with trastuzumab and pertuzumab for adults with unresectable, locally advanced or metastatic HER2-positive breast cancer after induction treatment.
The FDA approved tucatinib with trastuzumab and pertuzumab for maintenance treatment of adults with unresectable, locally advanced or metastatic HER2-positive breast cancer following induction treatment. The FDA announced the approval on October 7, 2026. The regimen is for patients whose cancer has not progressed after induction treatment with trastuzumab, pertuzumab and a taxane.
Median progression-free survival was 24.9 months with tucatinib and 16.3 months with placebo, each given with trastuzumab and pertuzumab. Tucatinib’s prescribing information includes a boxed warning for hepatotoxicity, and warnings for diarrhea, embryo-fetal toxicity and increased serum creatinine without affecting renal function.
