FDA Approves Pfizer Tukysa Combo for Metastatic Breast Cancer Maintenance

The FDA on October 7, 2026 approved Pfizer's Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as front-line maintenance treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. Tukysa was previously authorized for late-line treatment in advanced HER2-positive breast cancer. The decision is not an approval for early-stage breast cancer. In the Phase 3 HER2CLIMB-05 trial of 654 randomized adults, the regimen reduced the risk of disease progression or death by 36%. Median progression-free survival was 24.9 months with tucatinib versus 16.3 months with placebo, with both arms also receiving trastuzumab and pertuzumab. The FDA stated that overall-survival data were not mature at analysis. Prescribing information includes a boxed warning for hepatotoxicity. Tukysa worldwide Q2 2026 revenue was $138 million versus $132 million in Q2 2025; U.S. revenue was $96 million, down 11%. Pfizer total Q2 2026 revenue was $15,034 million. Pfizer's Q3 2026 earnings report and analyst call are scheduled for November 3, 2026. No factual disputes appear among the rated outlets in the record.