The U.S. Food and Drug Administration (FDA) has approved Kyprolis™ (carfilzomib) for the treatment of patients with multiple myeloma that has already been treated with at least two prior therapies—including Velcade® (bortezomib) and a drug such as thalidomide or lenalidomide—and that has worsened within 60 days of the last treatment.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.
Kyprolis is a type of targeted drug known as a proteasome inhibitor. The approval of Kyprolis was based in part on a study of 266 people with relapsed, previously treated multiple myeloma. Study participants received up to 12 cycles of treatment with Kyprolis.
Overall, 23% of patients responded to treatment (had a reduction in detectable myeloma). One patient had a complete response (a disappearance of detectable myeloma). The median duration of these responses was 7.8 months.
The most common side effects of Kyprolis are fatigue, anemia, nausea, low platelet counts, shortness of breath, diarrhea, and fever. Some patients experience serious side effects, including heart failure.
Kyprolis was approved under the FDA’s accelerated approval program. The accelerated approval program provides earlier access to promising drugs for life-threatening health conditions while confirmatory studies are conducted.
A Phase III trial of Kyprolis is ongoing, and the results of this study will be reported to the FDA once they are available. The study is comparing two treatments (lenalidomide plus low-dose dexamethasone versus lenalidomide plus low-dose-dexamethasone plus Kyprolis) in patients with relapsed or refractory myeloma.
Reference: FDA News Release. FDA approves Kyprolis for some patients with multiple myeloma. July 20, 2012.
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