SILVER SPRING, Md. -- An FDA advisory committee voted 11-0 with one abstention to recommend approval carfilzomib (Kyprolis) for patients with treatment-refractory multiple myeloma.
Members of the Oncologic Drugs Advisory Committee decided that the drug's promised benefits -- control of progressive disease in patients who have exhausted all other treatments -- outweighed the considerable risks.
"We need to put this in the context of patients who are really running out of options," said one panel member prior to the vote.
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