FDA Approves KYPROLIS® (carfilzomib) In Combination With Dexamethasone For Patients With Relapsed Or Refractory Multiple Myeloma

Amgen (NASDAQ:AMGN) recently announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS^® (SBECD-enabled 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 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 (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 interim data were presented during an oral session at the 54th Annual Meeting of the American Society of Clinical Oncology and simultaneously published in The Lancet Oncology.

About KYPROLIS^® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.⁵ In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.

Since its first approval in 2012, approximately 80,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:

• In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
• As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

KYPROLIS is also approved in Argentina, Australia, Bahrain, Canada, Hong Kong, Israel, Japan, Kuwait, Lebanon, Macao, Mexico, Thailand, Colombia, S. Korea, Canada, Qatar, Switzerland, United Arab Emirates, Turkey, Russia, Brazil, India, Oman and additional U.S. regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.