Amgen applies to FDA for once-weekly myeloma combo

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 rates (ORR), with a comparable safety profile versus the twice-weekly KYPROLIS at 27 mg/m² and dexamethasone (twice-weekly Kd).

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.

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