Amgen files sNDA for Kyprolis to include a once-weekly dosing option in combination with dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma.

Amgen announced the submission of a supplemental New Drug Application (sNDA) to the FDA to expand the Prescribing Information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma.

The sNDA is based on data from the Phase III A.R.R.O.W. trial, demonstrating Kyprolis administered once-weekly at 70 mg/m2 with dexamethasone (once-weekly Kd) achieved superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile versus the twice-weekly Kyprolis at 27 mg/m2 and dexamethasone (twice-weekly Kd). The FDA is reviewing the application under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

A.R.R.O.W. included 478 patients with relapsed and refractory multiple myeloma who received two or three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Patients treated with once-weekly Kd achieved a statistically significant 3.6 month improvement in PFS compared to the twice-weekly regimen (median PFS 11.2 months for once-weekly Kd versus 7.6 months for twice-weekly Kd; HR=0.69; 95 percent CI: 0.54-0.88; one-sided p=0.0014).The ORR in patients treated with once-weekly Kd was 62.9 percent versus 40.8 percent for those treated with the twice-weekly regimen (p<0.0001). in addition 7.1 percent had complete responses or better in the once-weekly arm versus 1.7 percent in the twice-weekly arm in this refractory patient population. the interim data were presented during an oral session at the 54th annual meeting of the american society of clinical oncology and simultaneously published in the lancet oncology.>