FDA Expands Indication for Ibrance to Include the Treatment of Men with Breast Cancer

On April 4, 2019, the FDA approved a new indication for palbociclib (Ibrance; Pfizer), an oral kinase inhibitor, for men with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

“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 Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

“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,” Dr Pazdur added.

The FDA initially granted palbociclib an accelerated approval in 2015 as part of a regimen in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with HR-positive, HER2-negative breast cancer. In 2016, palbociclib was approved for use in combination with ful­vestrant in women with HR-positive, HER2-negative metastatic breast cancer who had received endocrine therapy.

The most common (≥10%) adverse effects associated with palbociclib treatment were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.

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