FDA OKs New Use for Pfizer’s Breast Cancer DrugBy
The US Food and Drug Administration (FDA) has approved a new indication expanding the use of Pfizer’s Ibrance (palbociclib) 125-mg capsules, Pfizer's metastatic breast cancer therapy.
The drug is approved for treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Pfizer's supplemental new drug application (sNDA) for Ibrance was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.
Ibrance, a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, was first approved in February 2015 and also is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women.