FDA Expands Palbociclib Approval for Male Breast Cancer

The Food and Drug Administration (FDA) expanded the approved use of palbociclib (Ibrance) capsules plus endocrine therapy to treat male patients with hormone receptor (HR)—positive, HER2-negative advanced or metastatic breast cancer, according to an announcement by the agency.

Male breast cancer is a rare malignancy, making up for less than 1% of all breast cancer cases, but the majority express hormone receptors. While some breast cancer therapies have been approved for patients regardless of gender, others are specific for the treatment of women with the disease.

“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,” 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, in a statement.

Palbociclib, a kinase inhibitor, was originally approved in 2015 to be used in combination with an aromatase inhibitor as a first-line hormonal-based therapy for postmenopausal women or to be given with fulvestrant for men who had disease progression.

The most common adverse events (AEs) from palbociclib include: infection, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea, and thrombocytopenia. Other common AEs reported are rash, vomiting, decreased appetite, asthenia (abnormal physical weakness or lack of energy) and fever.

It is important for healthcare providers to monitor patients’ blood counts for neutropenia, which should be checked before starting palbociclib, at the beginning of each cycle, and on day 15 of the first two cycles, as clinically indicated.

“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,” said Pazdur in his statement.