Pomalyst (pomalidomide) has been approved by the FDA to treat cases of multiple myeloma that have not responded to other therapies.
The disease, a form of blood cancer, affects some 21,700 Americans annually and nearly 10,700 die from it each year, the agency said Friday in a news release.
Pomalyst is designed to spur the immune system to destroy and inhibit cancer cells, the FDA said. The drug's safety and effectiveness were evaluated in a clinical study of 221 people with advanced multiple myeloma.
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The drug's label will contain a boxed warning that it shouldn't be used by pregnant women since it can cause life-threatening birth defects and blood clots, the FDA said.
More common side effects could include a drop in infection-fighting white blood cells, fatigue, weakness, other blood disorders, back pain and fever.
The drug is marketed by Celgene, based in Summit, N.J.