FDA approval is being sought for a once-weekly dosing option of carfilzomib (Kyprolis) for use in combination with dexamethasone as a treatment for patients with relapsed/refractory multiple myeloma. Amgen, the manufacturer of the proteasome inhibitor, announced the submission of a supplemental new drug application (sNDA) seeking this approval today.
The application is based on results from the phase III ARROW study, in which carfilzomib administered once weekly at 70 mg/m2Â with dexamethasone resulted in a prolonged progression-free survival (PFS) compared with the standard twice-weekly schedule in patients with relapsed/refractory multiple myeloma.1,2
The findings showed a median PFS of 11.2 months (95% CI, 8.6-13.0) with once weekly carfilzomib and dexamethasone compared with 7.6 months (95% CI, 5.8-9.2) for the standard twice-weekly schedule of carfilzomib at 27 mg/m2with dexamethasone (HR, 0.69; 95% CI, 0.54-0.88;Â PÂ = .0029). These data met the primary endpoint of PFS.
Read more:Â https://www.targetedonc.com/news/onceweekly-carfilzomib-submitted-for-fda-approval-in-myeloma