Novel drug approved for multiple myeloma

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The U.S. Food and Drug Administration has approved Farydak (panobinostat) in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior standard therapies, including an immunomodulatory agent like thalidomide or lenalidomide and bortezomib.

“Farydak has a new mechanism of action that distinguishes it from prior drugs approved to treat multiple myeloma, making it a potentially attractive candidate agent for the treatment of multiple myeloma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Farydak’s approval is particularly important because it has been shown to slow the progression of multiple myeloma.”

The most common side effects associated with Farydak were diarrhea, nausea, decreased appetite, peripheral edema, vomiting, tiredness, and weakness. The most common laboratory abnormalities were hypokalemia, hypophosphatemia, hyponatremia, anemia, thrombocytopenia, and leukopenia.

According to the American Cancer Society's estimates, there will be about 26,850 new cases of multiple myeloma in the United States in 2015 and about 11,240 deaths.

Novel drug approved for multiple myeloma
The FDA has approved Farydak (panobinostat) in combination with bortezomib and dexamethasone for the treatment of multiple myeloma.
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.
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