Pfizer Gets Positive European Opinion for Breast Cancer Therapy
Pfizer has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending marketing authorization approval of Ibrance (palbociclib) in the European Union (EU) for women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
The CHMP’s positive opinion is for Ibrance to be used in combination with an aromatase inhibitor, as well as in combination with fulvestrant, in women who have received prior endocrine therapy. The CHMP’s opinion will now be reviewed by the European Commission. In the EU, Ibrance is an investigational agent and has not been approved.
In the US, Ibrance is approved by the US Food and Drug Administration (FDA) for the treatment of HR+/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 in the US under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Outside the US, Ibrance has received regulatory approval in 19 countries to date.