Suparna Wedam, Lola Fashoyin-Aje, Erik Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Kirsten B Goldberg, Marc R Theoret, Laleh Amiri-Kordestani, Richard Pazdur, Julia A Beaver
On April 4, 2019, the Food and Drug Administration (FDA) approved a supplemental new drug application for palbociclib (IBRANCE), to expand the approved indications in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (MBC) in combination with an aromatase inhibitor or fulvestrant, to include men. Palbociclib was first approved in 2015 for use in combination with letrozole for the treatment of estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women and subsequently in 2016 in combination with fulvestrant in women with HR-positive, HER2-negative advanced breast cancer with disease progression following endocrine therapy...
October 24, 2019: Clinical Cancer Research