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Affecting mostly older adults, the disease causes blood plasma cells to multiply rapidly, overtaking other healthy blood cells from the bone marrow. This can weaken the immune system and lead to bone and kidney problems, the FDA said in a news release.
Farydak inhibits enzymes called histone deacetylases (HDACs), which could slow the overproduction of plasma cells among people with multiple myeloma, the FDA said.
In November, an FDA advisory committee recommended against approving Farydak for people with relapsing multiple myeloma, saying its benefits did not outweigh its risks. But the drug's maker, Novartis, subsequently submitted additional information supporting the drug's use for people with multiple myeloma who had received at least two prior standard therapies, the FDA said.
The safety and effectiveness of Farydak in combination with bortezomib and dexamethasone were evaluated in clinical studies involving 193 people with multiple myeloma. People who received the three-drug combination saw a delay in disease progression of about 10.6 months, compared with 5.8 months among people who received the other two drugs alone.
Farydak's label includes a boxed warning of the potential for fatal or severe heart problems, and severe diarrhea, the FDA said.
Novartis is based in East Hanover, N.J.
-- Scott Roberts
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