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FDA Approves Once-Weekly Dose of Kyprolis for R/R Multiple Myeloma

Laura Joszt
A once-weekly dose of carfilzomib (Kyprolis) in combination with dexamethasone has been approved to treat patients with relapsed or refractory (R/R) multiple myeloma. The approved regimen improved progression-free survival and had a better overall response rate than a twice-weekly regimen.
Carfilzomib (Kyprolis) from Amgen has received approval from the FDA to expand the therapy’s indication to be used once weekly at 70 mg/m2 in combination with dexamethasone to treat patients with relapsed or refractory multiple myeloma (MM).

The new once-weekly dosing option is more convenient for patients and has a comparable safety profile with better outcomes. The FDA approved the new regimen based on results from the phase 3 A.R.R.O.W. trial, which compared the once-weekly regimen with a twice-weekly dose of carfilzomib at 27 mg/m2 in combination with dexamethasone, which is not an FDA-approved regimen.

Amgen submitted the supplemental New Drug Application at the end of August. In slightly more than 1 month the FDA had reviewed the application under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to streamline the review process to get safe and effective treatments to patients sooner. Amgen announced FDA’s decision on October 1.
"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 S. Siegel, MD, PhD, chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center, said in a statement. "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."

The A.R.R.O.W. trial evaluated 478 patients who were randomized to receive either the once-weekly regimen of carfilzomib or the twice-weekly regimen. Patients treated with the once-weekly regimen had a 3.7-month improvement in progression-free survival compared with the twice-weekly regimen, and the overall response rate in patients with the once-weekly regimen was 62.9% compared with 40.8% with the twice-weekly regimen.

The safety profiles between the 2 arms were similar and the most frequently reported treatment-emergent adverse events in either arm were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

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