Overall Survival Data Added to Labeling for Multiple Myeloma Drug Kyprolis

New data from the Phase 2 head-to-head ENDEAVOR trial
New data from the Phase 2 head-to-head ENDEAVOR trial

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.