EU approves combination therapy for relapsed multiple myeloma20 Nov 2015
Amgen announced the European Commission granted marketing authorization for carfilzomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Carfilzomib is the first irreversible proteasome inhibitor approved in the European Union (EU) for use in combination treatment of patients with relapsed multiple myeloma.
“The approval of carfilzomib in combination provides physicians and patients across Europe with an important new treatment option for relapsed multiple myeloma, helping to address a real unmet need for this rare blood cancer,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
“One out of three patients achieved a complete response or better”
The European Commission approved carfilzomib based on data from the pivotal Phase 3 ASPIRE trial. The study showed that:
- Patients treated with carfilzomib in combination with lenalidomide and dexamethasone (regimen referred to as KRd) had increased median time to progressive disease or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone (regimen referred to as Rd).
- The median progression-free survival was 26.3 months in the KRd arm compared to 17.6 months in the Rd arm.
- The most common adverse events in the carfilzomib arm included pneumonia (1%), myocardial infarction (0.8%) and upper respiratory tract infection (0.8%).
- Discontinuation of treatment due to adverse events occurred in 15% of patients in the KRd arm versus 18% of patients in the Rd arm.
“In clinical studies, approximately one out of three patients achieved a complete response or better on the carfilzomib in combination with lenalidomide and dexamethasone arm, which is three times more frequent than in the lenalidomide and dexamethasone arm,” said Prof. Meletios A. Dimopoulos, M.D., Department of Clinical Therapeutics, 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 drug will be available in the 28 member states of the EU
Approval from the EC grants a centralized marketing authorization with unified labelling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the European Commission.
Amgen plans to submit data from the Phase 3 ENDEAVOR trial for potential authorization of carfilzomib in combination with dexamethasone in the EU. This data also serves as the basis of the supplemental New Drug Application of carfilzomib in combination with dexamethasone for patients with relapsed multiple myeloma, which has been accepted for priority review by the U.S. Food and Drug Administration (FDA).Source: eCancer News