The Priority Review

Tag

HER2-positive breast cancer

1 story

Stories

  1. Approvals

    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.