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FDA Approves KYPROLIS® (carfilzomib) Once-Weekly 70 mg/m2 + Dexamethasone (Kd70) in relapsed Myeloma

Updated: Oct 18, 2021



Oct. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today 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® (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.


"In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. KYPROLIS now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We're pleased that the FDA has recognized the importance of bringing more treatment options to cancer patients more quickly through its pilot programs and proud to participate with this KYPROLIS data."


 

Learn more: https://www.amgen.com/newsroom/press-releases/2018/10/fda-approves-kyprolis-carfilzomib-onceweekly-70-mgm2-in-combination-with-dexamethasone-kd70-for-patients-with-relapsed-or-refractory-multiple-myeloma


09/28/2018: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s021ltr.pdf






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