FDA approves Kyprolis once-weekly dosing option + dexamethasone for relapsed or refractory multiple myeloma. Amgen

Amgen announced that the FDA has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma.

The approval is based on data from the Phase III A.R.R.O.W. trial, which demonstrated that Kyprolis administered once-weekly at 70 mg/m2 with dexamethasone achieved superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile, versus twice-weekly Kyprolis administered at a dose of 27 mg/m2 in combination with dexamethasone (twice-weekly Kd27). Kyprolis is not approved for twice-weekly 27 mg/m2 administration in combination with dexamethasone alone.

The FDA reviewed the application under its 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. The FDA approved the application in just over one month after the final component of the application was submitted.