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FDA Expands Use of IBRANCE®

On February 19, 2016, the FDA approved a new indication expanding the use of IBRANCE® (palbociclib). The new indication in combination with fulvestrant is supported by the results of PALOMA-3, a Phase 3 trial.1


IBRANCE is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:


• letrozole as initial endocrine-based therapy in postmenopausal women, or

• fulvestrant in women with disease progression following endocrine therapy


The indication in combination with letrozole is approved under accelerated approval

based on progression-free survival (PFS). Continued approval for this indication may

be contingent upon verification and description of clinical benefit in a confirmatory trial.


This first-in-class therapy is now approved for use in a broader range of women. Now, in addition to being a first-line treatment option in combination with letrozole, IBRANCE can also be used in combination with fulvestrant in patients with disease progression on or after prior endocrine therapy in the adjuvant or metastatic setting.

Click Here to read the announcement from Pfizer.