Amgen announced that the Food and Drug Administration (FDA) has approved the addition of overall survival (OS) data from the ENDEAVOR trial to the labeling for Kyprolis (carfilzomib).

The Phase 3 ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial included 929 patients treated with Kyprolis + low-dose dexamethasone versus Velcade + low-dose dexamethasone in relapsed or refractory patients who previously received at least 1 (but not more than 3) prior therapeutic regimens. The primary endpoint was progression-free survival. 

According to the new data, Kyprolis + dexamethasone lowered the risk of death by 21% and increased OS by 7.6 months compared with Velcade + dexamethasone in patients with relapsed or refractory multiple myeloma (median OS 47.6 months vs 40.0 months; hazard ratio [HR] 0.79; P=0.01). The full OS data have been published in The Lancet Oncology. 

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Kyprolis, a proteasome inhibitor, 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.
  • As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 or more lines of therapy.

Kyprolis is available as a 30mg or 60mg strength lyophilized powder in single-dose vials for intravenous injection after reconstitution.

For more information call (800) 772-6436 or visit Kyprolis.com.