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The European Commission (EC) has expanded the approved use of the proteasome inhibitor carfilzomib (Kyprolis).
The drug is now approved for use in combination with dexamethasone to treat adults with multiple myeloma (MM) who have received at least 1 prior therapy.
Carfilzomib was previously approved by the EC for use in combination with lenalidomide and dexamethasone to treat adult MM patients who have received at least 1 prior therapy.
The EC approved the extended indication for carfilzomib based on data from the phase 3 ENDEAVOR trial.
The trial included 929 MM patients whose disease had relapsed after 1 to 3 prior therapeutic regimens.
The patients received either carfilzomib plus dexamethasone (n=464) or bortezomib plus dexamethasone (n=465) until disease progression.
The primary endpoint was progression-free survival. The median progression-free survival was 18.7 months in the carfilzomib arm and 9.4 months in the bortezomib arm. The hazard ratio was 0.53 (P<0.0001).
Overall survival data were not yet mature at last follow-up.
Treatment discontinuation due to adverse events and on-study deaths were comparable between the 2 treatment arms.
However, a number of known adverse events were reported at a higher rate in the carfilzomib arm than the bortezomib arm, including dyspnea (28% vs 13%), hypertension (25% vs 3%), pyrexia (27% vs 14%), cough (25% vs 15%), cardiac failure (8% vs 3%), and acute renal failure (8% vs 5%).
Carfilzomib is marketed as Kyprolis by Onyx Pharmaceuticals, Inc., a subsidiary of Amgen that holds development and commercialization rights to the drug globally, with the exception of Japan.
