The IMF is pleased to announce that today the European Commission (EC) approved the use of Kyprolis® (carzfilzomib) for use in combination with lenalidodmide and dexamethasone to treat patients with multiple myeloma who have received at least one prior treatment.
According to Professor Meletios A. Dimopouls, MD, Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, “In clinical studies, approximately one out of three patients achieved a complete response or better on Krypolis® in combination with lenalidomide and dexamethasone arm, which is three times more frequent than in the lenalidomide and dexamethasone arm.” He noted that in patients with relapsed myeloma, “this regimen provided patients with more than two years without disease progression.”
Krypolis® (“kye-PRO-lis”) is the second drug to have been developed in a new class of drugs called proteasome inhibitors and approved by the US Food and Drug Administration (FDA). Proteasome inhibitors work by blocking the activity of enzyme complexes called proteasomes. Both normal cells and cancer cells contain proteasomes, which break down damaged and unwanted proteins into smaller components. Proteasomes also carry out the regulated breakdown of undamaged proteins in the cell, a process that is critical to cellular functions. These smaller components are then used to create new proteins required by the cell. Proteasomes can be thought of as crucial to the cell’s “recycling” of proteins.
Approval from the European Commission allows for centralized marketing authorization of the drug with unified labeling in the 28-member countries of the European Union. The members of the European Economic Area (Norway, Iceland, and Lichenstein) will make their decisions based on the decisions of the EC.
To learn more about AMGEN’s announcement of this approval, click HERE.