The European Commission granted marketing authorization for Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Kyprolis, sponsored by Amgen, is the first irreversible proteasome inhibitor approved in the European Union for use in combination treatment of patients with relapsed multiple myeloma.
“In clinical studies, approximately one out of three patients achieved a complete response or better on the Kyprolis in combination with lenalidomide and dexamethasone arm, which is three times more frequent than in the lenalidomide and dexamethasone arm,” said Prof. Meletios Dimopoulos of the National and Kapodistrian University of Athens School of Medicine. “In addition, the regimen provided patients with more than two years without disease progression. These results are significant for patients with relapsed multiple myeloma, who are faced with worse outcomes each time they experience a relapse.”
The EC approved Kyprolis based on data from the phase III ASPIRE trial. The study showed that patients treated with Kyprolis in combination with lenalidomide and dexamethasone had increased median time to progressive disease or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone.
The median progression-free survival was 26.3 months in the KRd arm compared to 17.6 months in the Rd arm (HR: 0.69; 95% CI: 0.57 to 0.83; p=0.0001).
The most common adverse events in the Kyprolis arm included pneumonia, myocardial infarction and upper respiratory tract infection. Discontinuation of treatment due to AEs occurred in 15 percent of patients in the KRd arm versus 18 percent of patients in the Rd arm.
Kyprolis received an accelerated assessment from the European Medicines Agency, and orphan drug designation in 2008.
