FDA Approval Sought for Once-Weekly Carfilzomib Regimen in Myeloma

August 27, 2018 – A supplemental new drug application (sNDA) has been submitted to the FDA for a once-weekly dosing option of carfilzomib to use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma, according to Amgen, the manufacturer of the proteasome inhibitor. The sNDA is based on results from the phase III ARROW study, in which carfilzomib administered once weekly at 70 mg/m2 with dexamethasone resulted in … (leggi tutto)