Palbociclib (Ibrance) provides a novel treatment option for women with advanced or metastatic disease. In February 2015, the American Food & Drug Administration (FDA) has granted accelerated approval for Palbociclib (Ibrance) in combination with Letrozole (Femara) for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine based therapy in postmenopausal women, followed by the February 2016 approval of Palbociclib (Ibrance) in combination with Fulvestrant (Faslodex) for the treatment of women with HR -positive, HER2 -negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
Following this, the European Medicines Agency (EMA) has now recommended granting a marketing authorisation in the European Union (EU) for Palbociclib (Ibrance) for the treatment of women with locally advanced or metastatic breast cancer. It is to be used for cancer that is HR-positive and HER2-negative. Palbociclib (Ibrance) works by blocking the activity of proteins known as cyclin-dependent kinases (CDK) 4 and 6. This inhibits the division of cancer cells and helps to stop growth of the tumour.
In postmenopausal women, Palbociclib (Ibrance) is to be used in combination with an aromatase inhibitor such as Letrozole (Femara) or with Fulvestrant (Faslodex) 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).
The recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on two main studies. One is a Phase III trial comparing treatment with Palbociclib (Ibrance) and Letrozole (Femara), with Letrozole (Femara) 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 (Femara) alone. The other study is a Phase III trial which compared treatment of Fulvestrant (Faslodex) together with Palbociclib (Ibrance) to treatment with only Fulvestrant (Faslodex). 521 women were enrolled in this trial, regardless of their menopausal status. Preliminary results showed that 347 patients who received Palbociclib (Ibrance) had an average of 11.2 months without their disease getting worse compared to 4.6 months for 174 patients who only received Fulvestrant (Faslodex).
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).
The opinion adopted by the CHMP at its September 2016 meeting is an intermediary step on Ibrance’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, a decision about price and reimbursement will then take place at the level of each Member State considering the potential role/use of the medicine in the context of the national health system of that country.
See the full announcement by the EMA here.