FDA approves tucatinib with trastuzumab and pertuzumab for HER2-positive breast cancer maintenance
On October 7, 2026, the FDA approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment. The approval follows a randomized, double-blind, placebo-controlled trial of 654 patients that showed a median progression-free survival of 24.9 months versus 16.3 months in the placebo arm.
Primary source
FDA approval notification, October 7, 2026
FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer
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