Posted by Michael Wonder on 17 Sep 2016
Pfizer receives positive CHMP opinion for Ibrance (palbociclib) in combination with endocrine therapy for the treatment of HR+/HER2-metastatic breast cancer in Europe
16 September 2016 - If approved, Ibrance would be the first medicine in a new class of anti-cancer treatments, cyclin-dependent kinase 4/6 inhibitors, to be approved by the European Commission.
Pfizer today announced that the CHMP of the EMA has adopted a positive opinion recommending that Ibrance (palbociclib) be granted marketing authorisation in the European Union 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 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.
