FDA Approves Palbociclib for Male Patients With HR+/HER2- Breast Cancer

The FDA has expanded the approval of palbociclib (Ibrance) 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 fulvestrant (Faslodex) in this patient population. In the study, the safety profile for men who received palbociclib is consistent with the tolerability in female patients who were treated with palbociclib. A detailed analysis of these data will be presented at an upcoming medical meeting.

“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.

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 electronic health records and postmarketing reports that the approval is based on is sourced from the IQVIA Insurance database, Flatiron Health Breast Cancer database, and the Pfizer global safety database, explained Pfizer, the manufacturer of palbociclib, in a press release.

"With this approval, we are now able to offer IBRANCE to the underserved male breast cancer community and provide more patients with HR-positive, HER2-negative metastatic breast cancer the opportunity to access an innovative medicine," said Chris Boshoff, MD, PhD, chief development officer, oncology, Pfizer Global Product Development, in the press release. "We appreciate that our partnership with the FDA has allowed us to take a significant step forward in the use of real-world data to bring medicines to patients who are most in need."

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 palbociclib for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer in 2016.

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.