FDA approves Pfizer's Tukysa regimen for front-line maintenance in HER2+ metastatic breast cancer
PFE•The FDA approved Pfizer's Tukysa with trastuzumab and pertuzumab for front-line maintenance in unresectable locally advanced or metastatic HER2+ breast cancer. In HER2CLIMB-05, median progression-free survival was 24.9 months versus 16.3 months with placebo; the label highlights higher hepatotoxicity risk, and one fatal drug-induced liver injury was reported in the trial.
1. Trial results and safety
The FDA cleared Pfizer’s Tukysa with trastuzumab and pertuzumab for front-line maintenance in unresectable locally advanced or metastatic HER2+ breast cancer. HER2CLIMB-05 showed median progression-free survival of 24.9 months versus 16.3 months for placebo, with a hazard ratio of 0.64; the label highlights higher hepatotoxicity risk, and one fatal drug-induced liver injury was reported in the trial.
