Multiple Myeloma Drug Kyprolis Gets FDA Approval

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Amgen Inc. revolutionary blood cancer drug Kyprolis has been fully approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with multiple myeloma. Taken together with other therapies, the cancer drug is proven to slow down the progression of the disease.

Reuters reported that FDA has approved Kyprolis as a single agent with relapsed or refractory multiple myeloma, given that patient has previously received other treatments already. The blood cancer drug was granted an accelerated initial approval in 2012 but was fully approved Jan. 21 as a single agent for the therapy of multiple myeloma.

Accelerated approval as explained by the news site is given to the drug based on the benefits expected from the drug. If the surrogate end point such as radiographic image and laboratory works supports the claimed benefits, the drug is given the accelerated approval.

On the other hand, the drug will be fully approved if the effects are proven through direct measure of how the patient feels and functions. Once studies establish the claimed benefits through an actual trial, the FDA then grants full approval for the drug.

Meanwhile, Pacific Coast Business Times provided details on what type of blood cancer Kyprolis is capable of treating. The news outlet reported that multiple myeloma is a type of blood cancer that forms in plasma cells, growing on bone marrows where blood cells are formed.

The disease remains incurable. Multiple myeloma kills patients by producing too many impaired plasma cells that affect the production of healthy blood cells. It is also characterized by recurring pattern of remission and relapse. It is known to be a rare but a very aggressive form of cancer.

Although there is no cure for the disease, the effects can be controlled. Kyprolis breaks down protein in cancer cells, ultimately killing the cancer cells.

In 2015, the American Cancer Society has predicted that 27,000 Americans will be diagnosed with multiple myeloma. From that number, 11,000 are expected to die. In 2012, there were 90,000 Americans suffering from the disease according to the National Cancer Institute.

"Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs," Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said via StreetInsider.

"Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer," Dr. Harper added.

The trial testing proved Kyprolis, if combined with the drug dexamethasone, doubled the length of time before the disease advances. The effect is more beneficial compared to its rival drug, Velcade with dexamethasone.

To know more about multiple myeloma, check out the video below: