Onyx wins FDA panel's backing for cancer drug
In a unanimous vote, government advisors said the benefits of a treatment for multiple myeloma outweigh the risks.
In an 11-0 vote, the panel of advisors said the benefits of the drug outweighed the risks for patients with multiple myeloma, a cancer of blood plasma cells.
The vote is a positive step toward Onyx winning U.S. approval for the medicine. The Food and Drug Administration is expected to decide on market clearance for the drug by July 27. The company is seeking approval to sell Kyprolis as a treatment for patients who have already received other therapies.
The advisory panel vote Wednesday followed a report by the FDA's own staff earlier this week that raised serious safety concerns about Kyprolis, which also goes by the chemical name carfilzomib. One panelist abstained from voting.
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