FDA expands indication of Ibrance to include HER2- breast cancer in males

The FDA is extending the indication of Ibrance (palbociclib), from Pfizer, capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. Ibrance was initially approved in 2015. It is a kinase inhibitor, approved in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy. Pfizer provided the results of an analysis of real-world data (RWD) from electronic health records (EHRs) as additional supportive data to characterize the use of palbociclib in combination with endocrine therapy (aromatase inhibitor or fulvestrant) in male patients with breast cancer based on observed tumor responses in this rare subset of patients with breast cancer.

The most common side effects of patients taking Ibrance are infections, leukopenia (low levels of white blood cells), fatigue, nausea, stomatitis (inflammation of the mouth and lips), anemia (low levels of red blood cells), hair loss, diarrhea and thrombocytopenia (low levels of thrombocytes, also known as platelets, in the blood). Other common side effects reported are rash, vomiting, decreased appetite, asthenia (abnormal physical weakness or lack of energy) and fever.