FDA’s expansion of the breast cancer drug palbociclib (Ibrance, Pfizer) to treat male patients is notable, analysts say.
FDA expanded the indication of Ibrance capsules, in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in male patients.
An important element of the expanded FDA approval for Ibrance is that it is based on real-world data from electronic health records and postmarketing reports showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance, Janet Serluco, vice president, Access Experience Team - Oncology Lead at Precision Medicine Group.
“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,” said Richard Pazdur, MD, director of 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.
However, breast cancer in males is rare. There will be an estimated 2,670 cases of male breast cancer in 2019—less than 1% of all cases of breast cancer, FDA said.
“For men, the lifetime risk of being diagnosed with breast cancer is about 1 in 1,000. Ibrance sales will likely still be driven by use in females undergoing treatment for hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2-) advanced or metastatic breast cancers,” Serluco said.
Ibrance, initially approved in 2015, costs at least $11,746 monthly, according to Sercluco. “Typically, there are patient support programs offered by manufacturers or non-profit foundation support to assist with patient cost share requirements driven by their insurance plans,” she said.
Because of the potential for genotoxicity (damage to cells), healthcare providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with Ibrance and for 3 months after the last dose, FDA said.