The Food and Drug Administration on Wednesday approved a new drug to treat patients with multiple myeloma, overruling a panel of outside cancer experts who expressed concerns about its toxicity.
The new multiple myeloma drug, called selinexor, will be marketed by Karyopharm Therapeutics under the brand name Xpovio.
The FDA cleared Xpovio under an accelerated, or conditional, approval based on a single-arm clinical trial showing a 25% tumor response rate. The patients enrolled in the clinical trial had advanced multiple myeloma no longer responsive to at least four prior therapies.
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