Palbociclib Approved by FDA for Treatment of Male Patients With HR+/HER2- Breast Cancer

The indication for palbociclib (Ibrance) capsules in combination with endocrine therapy now includes the treatment of male patients with hormone receptor (HR)—positive, HER2-negative advanced or metastatic breast cancer after being expanded by the FDA.

“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,” 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, said 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,” added Pazdur.

Real-world data from electronic health records showed encouraging response rates with the CDK4/6 inhibitor in combination with an aromatase inhibitor or fulvestrant (Faslodex) in this patient population. The safety profile for palbociclib in male patients was consistent with the tolerability in female patients who were treated with palbociclib, according to the data.

Male patients with breast cancer comprise less than 1% 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. Additionally, while some therapies are gender-neutral in their indication, others have been indicated only for women, although they are often prescribed for male patients. Current clinical practice standards state that male patients with breast cancer are treated similarly to women with the disease.

The FDA initially granted an accelerated approval to palbociclib 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 palbociclib for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer in 2016.

Reference:

FDA Expands Approved Use of Metastatic Breast Cancer Treatment to Include Male Patients. FDA. Published April 4, 2019. https://bit.ly/2Ie3UTx. Accessed April 4, 2019.