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Amgen: FDA Approves KYPROLIS Once-Weekly In Combination With Dexamethasone

Amgen (AMGN) announced the U.S. 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 for patients with relapsed or refractory multiple myeloma. KYPROLIS is not approved for twice-weekly 27 mg/m2 administration in combination with dexamethasone alone.

The company noted that the FDA reviewed the application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs. The FDA approved the application in just over one month after the final component of the application was submitted.

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