The FDA has expanded the approval of Ibrance (palbociclib) capsules in combination with endocrine therapy for male patients with hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer.
The FDA has expanded the approval of Ibrance (palbociclib) capsules in combination with endocrine therapy for male patients with hormone receptor (HR)—positive, HER2-negative advanced or metastatic breast cancer.
The approval is based on real-world data from electronic health records, which demonstrated encouraging response rates with the CDK4/6 inhibitor in combination with an aromatase inhibitor or Faslodex (fulvestrant) in this patient population.
“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, M.D., 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 press release. “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.”
Male patients with breast cancer comprise less than 1 percent of all breast cancer cases at approximately 2670 estimated in 2019, the majority of which are HR positive. Additionally, male patients are more likely to receive a breast cancer diagnosis at an older age and present with a more advance stage.
The FDA initially granted an accelerated approval to the CDK4/6 inhibitor with letrozole in the first-line setting for postmenopausal female patients with estrogen receptor—positive, HER2-negative metastatic breast cancer in 2015. This was converted to a full approval in March 2017.
The agency also approved Ibrance for use in combination with Faslodex in pretreated patients with HR-positive, HER2-negative metastatic breast cancer in 2016.
This article originally appeared on OncLive as, "FDA Approves Palbociclib for Male Patients With HR+/HER2- Breast Cancer."