Posted by Michael Wonder on 04 Apr 2019
FDA expands approved use of metastatic breast cancer treatment to include male patients
4 April 2019 - The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-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 from electronic health records as additional supportive data to characterise the use of palbociclib in combination with endocrine therapy (aromatase inhibitor or fulvestrant) in male patients with breast cancer based on observed tumour responses in this rare subset of patients with breast cancer.
