Pfizer Wins FDA Approval for Chemotherapy-Free TUKYSA Maintenance in HER2-Positive Breast Cancer

The U.S. Food and Drug Administration (FDA) approved Pfizer’s TUKYSA (tucatinib), in combination with trastuzumab and pertuzumab, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy. The approval expands TUKYSA’s use into the front-line maintenance setting and offers a chemotherapy-free option for these patients.

The approval was based on positive results from the Phase 3 HER2CLIMB-05 clinical trial, which showed a statistically significant improvement in progression-free survival (PFS) with the TUKYSA regimen compared with placebo.

Median PFS was 24.9 months with TUKYSA, versus 16.3 months with placebo.