A phase III trial of adjuvant Prolia (denosumab) therapy in postmenopausal women with early hormone receptor positive breast cancer receiving aromatase inhibitor therapy met its primary endpoint of time from randomization to first clinical fracture (HR=0.5, 95 percent CI 0.39-0.65, p<0.0001).
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
