FDA approves expanded use of Pfizer's Ibrance

The US Food and Drug Administration has approved a new indication for pharma giant Pfizer (NYSE: PFE), expanding the use of Ibrance (palbociclib) 125mg capsules, the firm’s metastatic breast cancer therapy.

Now Ibrance is also approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant (AstraZeneca’s Faslodex) in women with disease progression following endocrine therapy.

Pfizer’s supplemental New Drug Application (sNDA) for Ibrance, one of Pfizer’s key growth drivers, was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results from the Phase III PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.