The U.S. Food and Drug Administration approved a new drug for the treatment of multiple myeloma on Friday to be used in patients who have not responded to other methods of treatment.
The new medication named Pomalyst, or pomalidomide, is priced at about $10,500 per cycle---according to the Celgene, the pharmaceutical company that produces the new drug.
The typical course of treatment is estimated to be five cycles as observed from clinical trials.
"Pomalyst marks the second treatment to receive accelerated approval in the last seven months, which is unparalleled in any other cancer," the Multiple Myeloma Research Foundation said in a statement.
Kyrpolis is another drug that was approved by the FDA last July and is made by Onyx Pharmaceuticals Inc. and is also intended for use with patients who did not respond to prior treatment.
Celgene applied for approval under a mid-stage (Phase II) trial that consisted of patients being administered either pomalidomide in addition to a low dosage of the standard treatment of dexamethasone or just pomalidomide without any other drugs.
And out of the 91 patients evaluated in the trial, 34 percent of patients who took the dual drug combination responded to treatment, while 13 percent responded to just the pomalidomide alone.
Conclusive data from the trial, MM-002, showed that the median length of time a patient lived before relapsing was 4.7 months in the two-drug treatment and 2.7 months in the solo treatment.
But the FDA requires Celgene to list a "boxed warning" on Pomalyst to warn against the use of the drug in pregnant women because it can cause life-threatening birth defects as well as blood clots.
There is also a risk management program that Celgene is required to establish for Pomalyst---a drug that is intended to use the body's immune system to fight cancer cells.
Multiple myeloma is a type of cancer that starts out affecting plasma cells, cells that help your body fight infection by using antibodies, in bone marrow---according to the National Institutes of Health. The disease makes it difficult for bone marrow to produce health blood cells and platelets.
The NIH lists the symptoms of multiple myeloma, having mostly to do with the associated anemia that comes with the disease, but also include bone, back and rib pain as cancer cells grow in bone marrow.
Other symptoms include bleeding problems, brittle bones that break easily, anemia-related fatigue, inexplicable fevers and shortness of breath due to anemia.
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