Pomalyst Approved for Advanced Multiple Myeloma
FRIDAY, Feb. 8 -- Pomalyst (pomalidomide) has been approved by the U.S. Food and Drug Administration 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.
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.
The U.S. National Library of Medicine has more about multiple myeloma.
Posted: February 2013