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FDA Expands Approval of Ibrance for Breast Cancer

New indication in combo with fulvestrant

The US Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125 mg capsules (Pfizer, Inc.) in combination with fulvestrant. In February 2015, FDA granted accelerated approval for palbociclib in combination with letrozole for the treatment of HR-positive, HER-negative advanced breast cancer as initial endocrine based therapy in postmenopausal women.

Indication: The expanded indication of Ibrance is intended for the treatment of women with HR-positive, HER2-negative advanced, or metastatic breast cancer with disease progression following endocrine therapy.

Dosage/administration: The recommended dose and schedule of palbociclib is 125 mg daily for 21 consecutive days followed by 7 days off treatment in combination with fulvestrant treatment. The dose and schedule of fulvestrant is 500 mg intramuscularly on days 1, 15, 29 and once monthly thereafter.

Adverse reactions: The most frequently reported serious adverse reactions in patients receiving palbociclib plus fulvestrant were infections, pyrexia, neutropenia, and pulmonary embolism.

Citation: Pfizer receives expanded FDA approval for IBRANCE (palbociclib) in HR+, HER2- metastatic breast cancer. [news release]. New York, NY: Pfizer, Inc.; February 19, 2016: Accessed February 22, 2016.