Amgen's Kyprolis' new dosing option gets FDA nod
The Food and Drug Administration has approved Amgen’s Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone — once-weekly Kd70 — for patients with relapsed or refractory multiple myeloma.
"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," Amgen executive vice president of research and development David Reese said. "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."
"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," David Siegel, chief of the division of multiple myeloma at John Theurer Cancer Center at Hackensack University Medical Center, said. "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."
"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," Amgen executive vice president of research and development David Reese said. "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."
"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," David Siegel, chief of the division of multiple myeloma at John Theurer Cancer Center at Hackensack University Medical Center, said. "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."