Amgen has submitted a supplemental New Drug Application to the FDA to expand the prescribing information of carfilzomib (Kyprolis) to include a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma.
Based on research that showed carfilzomib (Kyprolis) administered once weekly prolonged progression-free survival (PFS) over the twice weekly schedule in patients with relapsed or refractory multiple myeloma (RRMM), Amgen has submitted a supplemental New Drug Application to the FDA to expand the prescribing information of carfilzomib to include a once-weekly dosing option in combination with dexamethasone for this patient group.
Patients on the once-weekly treatment of 70 mg/m2 had median PFS of 11.2 months compared with 7.6 months for patients taking the treatment twice weekly, at 27 mg/m2, according to research published in The Lancet Oncology and presented at the American Society of Clinical Oncology Annual Meeting.
"Data from the phase 3 A.R.R.O.W. study illustrates Kyprolis’ potential to extend the time patients live without their disease progressing while also providing a more convenient once-weekly dosing option for this frequently relapsing and difficult-to-treat cancer,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a statement. “We look forward to working with the Agency to bring this more streamlined dosing regimen to patients."
The A.R.R.O.W. trial evaluated 478 patients who were randomized to receive either a 30-minute infusion of carfilzomib once a week with dexamethasone or a 10-minute infusion of carfilzomib twice a week with dexamethasone. The safety profiles between the 2 arms were similar and the most frequent treatment-emergent adverse events reported were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.
The application will be reviewed under FDA’s 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.
Currently, carfilzomib is approved for use with dexamethasone or lenalidomide plus dexamethasone to treat patients with relapsed or refractory MM who have received 1 to 3 lines of therapy and as a single agent to treat patients with RRMM who have received at least 1 line of therapy.
Moreau P, Mateos M-V, Berenson JR, et al. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018;19(7):953-964. doi: 10.1016/S1470-2045(18)30354-1.