The US FDA has approved a supplemental New Drug Application (sNDA) from Pfizer (NY, USA) to expand the use of IBRANCE®, in combination with an aromatase inhibitor or fulvestrant, to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
This approval comes after real world data, from the IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database, shows that there is little disparity between the safety profile of men treated with Ibrance and women undergoing the same treatment.
“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,” commented Chris Boshoff, Chief Development Officer, Oncology, Pfizer Global Product Development. “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.”
As men are less likely to develop breast cancer, fewer clinical trials and fewer treatment options are available. However, real-world data is having an impact in expanding the use of already approved medicines. The 21st Century Cures Act of 2016, which aims to accelerate medicinal product development, places additional focus on the use of real-world data to support regulatory decision-making. With this, new innovations and advances will hopefully become available to those who need them faster and more efficiently.
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” commented Bret Miller, Founder of the Male Breast Cancer Coalition. “We applaud the use of real-world data, a new approach to drug review, to make Ibrance available to certain men with metastatic breast cancer and help address an unmet need for these patients.”
This approval makes Ibrance the first and only CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of men with HR+, HER2- metastatic breast cancer in the US.