Posted by Michael Wonder on 02 Apr 2017
Ibrance (palbociclib) receives FDA regular approval and expanded indication for first-line HR+, HER2- metastatic breast cancer
31 March 2017 - Pfizer today announced that the U.S. FDA has approved a supplemental new drug application for its first-in-class cyclin dependent kinase 4/6 inhibitor, Ibrance (palbociclib), based on the results from the confirmatory Phase 3 trial PALOMA-2.
The FDA action converts the accelerated approval of Ibrance to regular approval and broadens the range of anti-hormonal therapy that may be administered with Ibrance.
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.
