FDA Expands Indication for Metastatic Breast Cancer Treatment

The FDA has converted the accelerated approval of Ibrance (palbociclib) to regular FDA approval and approved a supplemental New Drug Application for the drug, broadening the range of antihormonal therapy that is allowed to be administered with it. The drug is now indicated for use in combination with an aromatase inhibitor 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.

The cyclin dependent kinase 4/6 inhibitor originally received accelerated approval in February 2015 and regular approval in February 2016 for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.

The new approval and indication are based upon the results from the Phase 3 PALOMA-2 trial, which evaluated Ibrance as a first-line therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive (ER+), HER2 metastatic breast cancer. Overall, the combination of Ibrance and letrozole significantly extended progression-free survival compared with letrozole plus placebo, with a median progression-free survival exceeding 2 years.

The most common grade 3/4 adverse reactions observed with Ibrance plus letrozole vs placebo plus letrozole were neutropenia, leukopenia, infections, and anemia.

—Michael Potts


IBRANCE® (palbociclib) receives FDA regular approval and expanded indication for first-line HR+, HER2- metastatic breast cancer [press release].