The European Medicines Agency (EMA) has suggested conceding a marketing endorsement in the European Union (EU) for Ibrance for the treatment of women metastatic breast cancer.
This treatment will be effective for cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. Hormone receptor positive breast cancer accounts for 65% of tumors in women aged 35 to 65 years and 82% of tumors in women older than 65 years.
Breast cancer is the most common cancer in women globally, with almost 1.7 million new cases diagnosed in 2012. In Europe, there were probably 464,000 new cases of breast cancer in 2012 and an anticipated 131,000 deaths from the disease.
The commendation 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 and letrozole, an aromatase inhibitor, with letrozole treatment alone. 444 patients who received palbociclib in this testing 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 registered in this trial, despite of their menopausal condition. Initial 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 major side effects related with myelosuppression, a state in which the patient’s bone marrow produces less blood cells than normal. Other side effects included:
- Infections
- Fatigue
- Nausea
- Vomiting
- Inflammation of stomatitis
- Diarrhea
- Hair loss
The judgment approved by the CHMP at its September 2016 meeting is a mediator step on Ibrance’s trail to patient access. The CHMP opinion will now be sent to the European Commission for the acceptance and implementation of a decision on an EU-wide marketing authorization.
Date: 16/09/2016