Regulatory clearance was based on findings from the double-blind, placebo-controlled Phase III HER2CLIMB-05 trial.
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The HER2CLIMB-05 trial is a randomized, double blind, placebo-controlled, pivotal Phase 3 study evaluating the efficacy and safety of TUKYSA compared to placebo, both in combination with trastuzumab ...
Pfizer said the Food and Drug Administration approved Tukysa as a front-line maintenance treatment for people with a form of breast cancer.