EU CHMP recommends approval of Ibrance (palbociclib) for breast cancer- Pfizer

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Ibrance (palbociclib), from Pfizer, for the treatment of women with locally advanced or metastatic breast cancer. It is to be used for cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.

The recommendation is based on two main studies. One is a Phase III trial comparing treatment with palbociclib and letrozole, an aromatase inhibitor, with letrozole treatment alone. 444 patients who received palbociclib in this trial lived on average 24.8 months without their disease getting worse, compared to 14.5 months in the group of 222 patients that received letrozole alone. The other study is a Phase III trial which compared treatment of fulvestrant together with palbociclib to treatment with only fulvestrant. 521 women were enrolled in this trial, regardless of their menopausal status. Preliminary results showed that 347 patients who received palbociclib had an average of 11.2 months without their disease getting worse compared to 4.6 months for 174 patients who only received fulvestrant.

The most frequently reported side effects are associated with myelosuppression, a condition in which the patient�s bone marrow produces fewer blood cells than normal. Other side effects included infections, fatigue, nausea and vomiting, inflammation of the lining of the mouth (stomatitis), diarrhoea and hair loss (alopecia).

Comment: In postmenopausal women, Ibrance is to be used in combination with an aromatase inhibitor or with fulvestrant in cases where the patient has undergone prior hormone therapy. For women in stages preceding menopause, the hormone therapy should be combined with a luteinizing hormone releasing hormone (LHRH).