FDA 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.
The drug is sponsored by Pfizer.
“Today we are expanding the indication for Ibrance to include male patients based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Some approved indications for breast cancer treatments do not distinguish by gender, but in certain cases if there is a concern that there may be a difference in efficacy or safety results between men and women, then further data may be necessary to support a labeling indication for male patients.”
Breast cancer is rare in males with only 2,670 cases of male breast cancer estimated in 2019 – less than 1% of all cases of breast cancer. The majority of breast tumors in male patients express hormone receptors.
Men are more likely to be diagnosed at an older age, with a more advanced stage of disease. Metastatic breast cancer is breast cancer that has spread beyond the breast to other organs in the body (most often the bones, lungs, liver, or brain).
When breast cancer is hormone-receptor positive, patients may be treated with hormone therapy (also called endocrine therapy) or chemotherapy. Endocrine therapy slows or stops the growth of hormone-sensitive tumors by blocking the body’s ability to produce hormones or by interfering with effects of hormones on breast cancer cells.
There are several FDA-approved endocrine based therapies available for HR-positive metastatic breast cancer patients. Certain treatments are gender-neutral in their indication, but some therapies have been approved only for women, although they are often prescribed for male patients. According to the current clinical practice standards, male patients with breast cancer are treated similarly to women with breast cancer.
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 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.
