The Food and Drug Administration warned that patients taking the drug carfilzomib in company studies had a high rate of heart and lung side effects, some which were fatal. The FDA posted its review of the drug ahead of a Wednesday meeting of its cancer drugs panel.
Onyx has asked the FDA to approve carfilzomib as a treatment for patients with advanced forms of multiple myeloma whose disease has spread despite treatment with other drugs.
Onyx shares fell almost 5 percent in premarket trading.
Multiple myeloma affects plasma cells in bone marrow. Over 50,000 people have the disease in the U.S., and about 20,000 new cases are diagnosed every year.
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