EU approves Ibrance (palbociclib) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. - Pfizer

Pfizer Inc. announced that the European Commission (EC) has approved Ibrance (palbociclib) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval also covers the use of Ibrance in combination with fulvestrant in women who have received prior endocrine therapy. Ibrance is the first medicine to be approved in Europe that works by inhibiting cyclin-dependent kinases 4 and 6 (CDK 4/6). It also is the first new medicine approved for the treatment of women with this type of metastatic breast cancer in the first-line setting in nearly 10 years. Women with HR+/HER2- metastatic breast cancer represent about 60 percent of all metastatic breast cancer cases.

The EC approval is based on a robust submission package including results from the Phase II PALOMA-1 trial in postmenopausal women with estrogen receptor-positive (ER+)/HER2- metastatic breast cancer who had not received prior systemic therapy for their advanced disease, the Phase III PALOMA-2 trial in the same population and the Phase III PALOMA-3 trial in women with HR+/HER2- metastatic breast cancer who had progressed on prior endocrine therapy. All three randomized trials demonstrated that Ibrance in combination with an endocrine therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone or endocrine therapy with placebo.