FDA Approves Ibrance Combo Therapy for Some Male Breast Cancers

FDA Approves Ibrance Combo Therapy for Some Male Breast Cancers
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 trea
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