Posted by Michael Wonder on 27 Aug 2018
Amgen submits supplemental new drug application for Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone
27 August 2018 - Filing based on data from Phase 3 head-to-head A.R.R.O.W. study.
Amgen today announced the submission of a supplemental new drug application to the U.S. FDA 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 application 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 achieved superior progression-free survival and overall response rates, with a comparable safety profile versus the twice-weekly Kyprolis at 27 mg/m2 and dexamethasone.
The FDA is reviewing the application under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
