The US Food and Drug Administration (FDA) has approved a weekly once dosing option for Amgen blood cancer drug Kyprolis (carfilzomib) in combination with dexamethasone (once-weekly Kd70) for patients having relapsed or refractory multiple myeloma.
The prescribing information has been expanded to include a new weekly once dosing of 70 mg/m2 of KYPROLIS.
Approval for the new dosing option was driven by the findings of the phase 3 A.R.R.O.W. trial, which showed that the Amgen blood cancer drug Kyprolis at 70 mg/m2 when administered weekly once with dexamethasone recorded superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile, in comparison to Kyprolis administered weekly twice at a dose of 27 mg/m2 in combination with dexamethasone.
David S. Siegel – chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center, commenting on the approval of the new dosing option of the Amgen blood cancer drug Kyprolis, said: “While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs.
“The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy versus the twice-weekly regimen studied in the trial could allow patients to spend more time outside of the infusion center.”
Kyprolis has not been approved by the FDA for weekly twice 27 mg/m2 administration in combination with dexamethasone alone, said Amgen.
Commenting on the approval of the new dosing option of the Amgen blood cancer drug Kyprolis, David M. Reese – executive vice president of Research and Development at Amgen, said: “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.
“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.”
Kyprolis, which was first approved in 2012, has been known to inhibit proteasomes, which play a key role in cell function and growth by breaking down proteins that are damaged or no longer required. Through its action, the Amgen blood cancer drug Kyprolis leads to a surplus build-up of proteins within cells and in some of them, it can cause death of cells, particularly in myeloma cells as they are more likely to have a larger amount of abnormal proteins.