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FDA Approval Sought for Once-Weekly Carfilzomib Regimen in Myeloma

Published: Monday, Aug 27, 2018

David M. Reese, MD
David M. Reese, MD
A supplemental new drug application (sNDA) has been submitted to the FDA for a once-weekly dosing option of carfilzomib (Kyprolis) to use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma, according to Amgen, the manufacturer of the proteasome inhibitor.

Carfilzomib is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy. The proteasome inhibitor is also approved as a single agent for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more lines of therapy.

References

  1. Mateos MV, Moreau P, Berenson JR, et al. Once-weekly vs twice-weekly carfilzomib (K) dosing plus dexamethasone (d) in patients with relapsed and refractory multiple myeloma (RRMM): Results of the randomized phase 3 study A.R.R.O.W. J Clin Oncol. 2018;36(suppl; abstr 8000).
  2. Moreau P, Mateos MV, 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 randomized, phase 3 study [Published online June 1, 2018]. Lancet. doi: https://doi.org/10.1016/S1470-2045(18)30354-1.

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