The U.S. Food and Drug Administration (FDA) has expanded the use of Ibrance (palbociclib) capsules in combination with an aromatase inhibitor or Faslodex (fulvestrant) to men with a subset of advanced breast cancer.
The approval of Pfizer’s supplemental New Drug Application (sNDA) makes such first-line treatment available for men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. Full prescribing information can be found here.
The decision was based on electronic health records and post-marketing reports of the real-world use of Ibrance in men from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database, and the Pfizer global safety database.
“With this approval, we are now able to offer Ibrance to the underserved male breast cancer community and provide more patients with HR+, HER2- metastatic breast cancer the opportunity to access an innovative medicine,” Chris Boshoff, MD, PhD, chief development officer, oncology, Pfizer Global Product Development, said in a press release.
Bret Miller, founder of the Male Breast Cancer Coalition, said: “Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important.”
Pfizer will present detailed data of the use of Ibrance in men with this type of advanced breast cancer at an upcoming medical meeting. According to information from post-marketing reports and electronic health records, the safety profile of treatment with Ibrance is similar in men and women, which was key for this latest approval of Ibrance.
“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,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in another press release.
The use of real-world data has been increasingly important to expand the indications of already- approved therapies. Breast cancer is rare in men, which leads to fewer clinical trials and treatment options.
The 21st Century Cures Act, enacted in 2016, was designed to help accelerate treatment development. It puts additional focus on real-world data to support regulatory decision-making.
Boshoff and Miller applauded the use of real-world data to reach this decision.
Ibrance is an oral blocker of enzymes known as cyclin-dependent kinase 4 and 6, which are crucial regulators of the cell cycle.
In the U.S., a combination treatment with Ibrance and an aromatase inhibitor — intended to stop estrogen production — is now approved for adults with HR-positive, HER2-negative metastatic breast cancer as first-line therapy in postmenopausal women or in men. In turn, Ibrance combined with Faslodex — a selective estrogen receptor degrader — is approved for patients experiencing disease progression after endocrine (hormone) therapy.
Because of the potential damage to cells, men who have female partners of childbearing age are advised to use contraception while on Ibrance and for three months after the last dose.