Adding tucatinib lengthened the time before HER2-positive breast cancer progressed
In a 654-person maintenance trial, median progression-free survival was 24.9 months with tucatinib and 16.3 months with placebo. Overall survival is not known yet.
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On October 7, 2026, the FDA approved tucatinib, given with trastuzumab and pertuzumab, as maintenance treatment for adults with HER2-positive breast cancer that cannot be removed by surgery or has spread, after induction treatment. The trial, HER2CLIMB-05, enrolled 654 adults whose cancer had not grown after four to eight cycles of trastuzumab, pertuzumab, and a taxane. Some already had cancer in the brain. They were randomly assigned to tucatinib or a placebo, twice a day, while continuing trastuzumab and pertuzumab, until the cancer grew or side effects were unacceptable.
The cancer took longer to progress with tucatinib: a median of 24.9 months, compared with 16.3 months on placebo. The hazard ratio was 0.64. Overall survival numbers were not ready, so the trial has not shown that people live longer. The label carries a boxed warning for liver toxicity. It also warns about diarrhea, harm during pregnancy, and a rise in a blood-creatinine reading that does not mean the kidneys are failing. The approval covers this maintenance use. It is not a claim that the cancer is gone.
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