Posted by Michael Wonder on 02 Oct 2018
FDA approves Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone for patients with relapsed or refractory multiple myeloma
1 October 2018 - Application reviewed and approved under FDA's real-time oncology review and assessment aid pilot programs.
Amgen today announced that the U.S. FDA has approved the supplemental new drug application to expand the Prescribing Information for Kyprolis (carfilzomib) to include a once weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma.
The approval is based on data from the Phase 3 A.R.R.O.W. trial, which demonstrated that Kyprolis administered once weekly at 70 mg/m2 with dexamethasone achieved superior progression-free survival and overall response rate, with a comparable safety profile, versus twice weekly Kyprolis administered at a dose of 27 mg/m2 in combination with dexamethasone. Kyprolis is not approved for twice weekly 27 mg/m2 administration in combination with dexamethasone alone.
