New Ibrance FDA approval : The US Food and Drug Administration (FDA) has extended the approval of Pfizer breast cancer drug Ibrance (palbociclib) to cover the treatment of hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
Under the new indication approved by the regulator, the Pfizer breast cancer drug is to be used in combination with specific endocrine therapies.
Ibrance, which is a kinase inhibitor was initially approved by the FDA in 2015 in combination with an aromatase inhibitor as a hormonal-based therapy in women, who have gone through menopause, and in men, or with fulvestrant in patients whose condition progressed after hormonal therapy.
Commenting on the latest Ibrance FDA approval, Richard Pazdur – 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: “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.
“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.”
The latest Ibrance FDA approval means that the Pfizer breast cancer drug is the first CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line therapy for male patients having HR+, HER2- metastatic breast cancer in the US.
Chris Boshoff – Chief Development Officer, Oncology, Pfizer Global Product Development, commenting on the latest Ibrance FDA approval, said: “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.
“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.”