FDA broadens the range of anti-hormonal therapy that may be administered with Ibrance (palbociclib) to treat breast cancer.- Pfizer
Pfizer Inc.has announced that the FDA has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib), based on the results from the confirmatory Phase III 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 (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
Comment: Today, Ibrance plus letrozole is the most prescribed FDA-approved oral combination treatment for HR+, HER2- metastatic breast cancer.
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