Kyprolis FDA Approval Expanded for Relapsed or Refractory Multiple Myeloma

Yesterday, the FDA expanded approval for Kyprolis (carfilzomib) to be used as a single agent, to be used with dexamethasone, or as a combination therapy with Revlimid and dexamethasone for patients with relapsed or refractory multiple myeloma. The announcement gives providers greater flexibility in using the proteasome inhibitor. It can now be used alone, in combinations and in different doses. In July of last year, Kyprolis was approved with Revlimid and dexamethasone for patients who had had 1-3 prior lines of therapy and in September was given priority FDA approval to be used with dexamethasone alone.  Yesterday's approval gives it more broad use in  greater number of treatment settings.

"Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs," Sean E. Harper, executive vice president of Research and Development at Amgen, said in a statement. "Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."

The approval was based on results from the Phase 3 ENDEAVOR trial which compared Kyprolis and dexamethasone with Velcade and dexamethasone. The study included the option to increase the dose of Kyprolis as tolerated. Investigators are now testing new uses of Kyprolis to determine the most effective use and dose. For example, Dr. James Berenson presented results from the CHAMPION-1 study at ASH 2015 showing the benefits of giving Kyprolis as a weekly treatment(20/70 mg/m²) compared to a bi-weekly lower dose (20/27 mg/m² administered twice-weekly) in the ongoing phase 3 superiority study ARROW (NCT02412878). To learn more, read the full announcement in Cure Today