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FDA: Pomalyst Approved for Advanced Multiple Myeloma

After other therapies have failed

MONDAY, Feb. 11 (HealthDay News) -- 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.

Multiple myeloma 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 neutropenia, fatigue, weakness, other blood disorders, back pain, and fever.

The drug is marketed by Celgene, based in Summit, N.J.

More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm338895.htm )