Amgen Submits Supplemental New Drug Application For KYPROLIS ® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone

Filing Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study THOUSAND OAKS, Calif., Aug. 27, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma. The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS administered once-weekly at 70 mg/m2 with dexamethasone (once-weekly Kd) achieved superior progression-free survival (PFS) and overall response rat...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news