The United States Food and Drug Administration (FDA) recently approved a new treatment combination consisting of Kyprolis (carfilzomib) plus dexamethasone for patients with relapsed or refractory multiple myeloma.
Multiple myeloma is a type of blood cancer that affects certain immune cells called plasma cells. Healthy plasma cells produce proteins called antibodies that are an important part of the immune system’s defense for fighting bacteria and viruses.
Cancerous plasma cells tend to replicate at a fast pace, crowding out other healthy immune cells, as well as producing malfunctioning antibodies. These antibodies tend to cause damage to the kidneys, in addition to reducing the immune system’s ability to efficiently fight infection.
Kyprolis is part of a class of drugs referred to as proteasome inhibitors that produce anti-cancer effects by disrupting a specific cellular process.
Normal cellular processes include the breakdown of proteins that are no longer being used. It is important for cells to get rid of the used proteins to function normally. Proteasomes, structures found in healthy cells, play an important role in the breakdown and recycling of these used proteins.
Proteasomes break down the used proteins and recycle them into new, usable proteins. This both prevents the accumulation of used proteins within a cell, as well as provides the body with new proteins that can be used for specific functions.
Proteasome inhibitors block proteasomes from breaking down used proteins. The used proteins then accumulate within the cell, often causing cellular death.
Kyprolis is already approved as a single-agent for the treatment of patients with multiple myeloma who have received at least one prior therapy; or in combination with Revlimid (lenalidomide) plus dexamethasone for patients with recurrent multiple myeloma who have received one to three prior treatment strategies. Now, Kyprolis is approved for use in combination with dexamethasone for patients with recurrent multiple myeloma who have received one to three prior treatments.
The new approval is based upon results from the phase III trial referred to as the ENDEAVOR study. The trial included 929 patients who had received one to three prior therapies, but had experienced a recurrence of their disease. Patients were treated with either Kyprolis plus dexamethasone, or Velcade (bortezomib)—another proteasome inhibitor approved for multiple myeloma—plus low-dose dexamethasone.
- The median progression-free survival (time from initiation of treatment until disease progression or death) was approximately 18.7 months for patients treated with Kyprolis/dexamethasone, compared with only 9.4 months for patients treated with bortezomib/dexamethasone.
- Overall, the tolerability of Kyprolis/dexamethasone was comparable to that of bortezomib/dexamethasone.
- Overall anti-cancer responses occurred in 77% of patients treated with Kyrpolis/dexamethasone and 63% of patients treated with bortezomib/dexamethasone.
- Survival data are not yet mature enough to determine any differences in treatment regimens; however, this data will be updated upon maturity.
Reference: Amgen press release. FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma. Available at: http://www.amgen.com/media/news-releases/2016/01/fda-approves-new-kyprolis-carfilzomib-combination-therapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/. Accessed January 22, 2016.
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