FDA Expands Palbociclib Indication in HR-Positive, HER2-Negative Breast Cancer to Include Male Patients
Today, the U.S. Food and Drug Administration (FDA) extended the indication of palbociclib (Ibrance) capsules in combination with specific endocrine therapies for hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer to include male patients.
“Today, we are expanding the indication for palbociclib to include male patients based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with palbociclib is consistent with the safety profile in women treated with palbociclib,” said Richard Pazdur, MD, 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. “Some approved indications for breast cancer treatments do not distinguish by [sex], 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.”
More About Male Breast Cancer
Breast cancer is rare in men, 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 and at a more advanced stage of disease.
There are several FDA-approved endocrine based therapies available for patients with HR-positive metastatic breast cancer. Certain treatments are not sex-specific 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.
More About Palbociclib
Palbociclib was initially approved by the FDA 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 or with fulvestrant in patients whose disease progressed following hormonal therapy. Palbociclib’s manufacturer, 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.
The most common side effects of patients taking palbociclib are infections, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea, and thrombocytopenia. Other common side effects reported are rash, vomiting, decreased appetite, asthenia, and fever. Health-care providers are advised to monitor a patient’s blood count for neutropenia.
Because of the potential for genotoxicity (damage to cells), health-care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with palbociclib and for 3 months after the last dose.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
