The U.S. FDA approved a supplemental new drug application for Pfizer Inc.'s Ibrance based on the results of a phase 3 trial.
The FDA action converts the accelerated approval of Ibrance to regular approval and broadens the range of antihormonal therapy that may be administered with Ibrance.
Results from the study showed that the combination of Ibrance and letrozole significantly extended progression-free survival, or the amount of time before tumor growth, compared with letrozole plus placebo.
Ibrance now is indicated in combination with an aromatase inhibitor, expanding on its earlier indication in combination with letrozole, as initial endocrine-based therapy in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
The agency granted the drug accelerated approval in combination with letrozole in February 2015 and regular approval in February 2016 for a second indication; the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression after endocrine therapy.