FDA Extends Indication of Palbociclib Combination to Men With Breast Cancer
Posted: Friday, April 5, 2019
Yesterday, the U.S. Food and Drug Administration (FDA) extended the indication of palbociclib (Ibrance) capsules in combination with specific endocrine therapies for hormone receptor–positive, HER2-negative advanced or metastatic breast cancer to include male patients.
There are several FDA-approved endocrine based therapies available for patients with hormone receptor–positive metastatic breast cancer. Certain treatments are not sex-specific in their indication, but some therapies have been approved for women alone, 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.
The most common side effects associated with the use of 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 cell count for neutropenia.
Because of the potential for genotoxicity, health-care providers are advised to tell male patients who have female partners of reproductive potential to use effective contraception during treatment with palbociclib and for 3 months after the last dose.
