FDA approves Pfizer’s IBRANCE to treat metastatic cancer

Pfizer Inc. announced last week that the United States Food and Drug Administration (FDA) has approved the expanded use of the drug IBRANCE (palbociclib).

IBRANCE is a 125mg capsule developed by Pfizer to combat metastatic breast cancer.

IBRANCE has also been approved to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) and advanced cases of metastatic breast cancer by being combined with fulvestrant for women whose disease has progressed after receiving the endocrine therapy.

Pfizer submitted a supplemental New Drug Application (sNDA) for IBRANCE, which was then given a Priority Review before being given a Breakthrough Therapy designation by the FDA following the results of the Phase 3 PALOMA-3 trial. The trial was conducted on women who were pre-, peri- and post-menopausal who had been diagnosed with HR+ and HER2- metastatic breast cancer and had the disease progress after receiving endocrine therapy.

The FDA first approved IBRANCE in February of last year to be combined with letrozole to treat HR+ and HER2- metastatic cancer as part of endocrine-based therapies in postmenopausal women. The combination of the two drugs is currently approved under accelerated approval, which is based on progression-free survival (PFS).

Continued approval hinges on further trials.