CHMP recommends Kyprolis (carfilzomib) + lenalidomide + dexamethasone to treat multiple myeloma- Amgen

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinion recommending 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.

Comment: Kyprolis is a proteasome inhibitor for use in the treatment of patients with relapsed multiple myeloma. Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. Kyprolis blocks proteasomes, which leads to an excessive build-up of proteins within cells. In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.

Comment: The ASPIRE trial data presented at ASH 2014 expanded on prior top-line results, which showed an 8.7-month median progression-free survival (PFS) benefit. Median PFS, the ASPIRE study's primary endpoint, was 26.3 months for patients treated with Kyprolis, Revlimid (lenalidomide) and dexamethasone (KRd) versus 17.6 months for Revlimid and dexamethasone.