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Pharmaceuticals / Regulatory Affairs

FDA Advisory Committee Votes to Delay Myeloma Drug Approval

March 5, 2019
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The FDA’s Oncologic Drugs Advisory Committee voted 8 to 5 last week in favor of delaying the approval of Karyopharm Therapeutics’ NDA for selinexor, a multiple myeloma treatment, pending the results of a Phase 3 trial.

Heidi Klepin, an associate professor of internal medicine at Wake Forest University Health Sciences, voted “yes” and said the delay was necessary for patient safety.

David Harrington, a professor of biostatistics at the Harvard T.H. Chan School of Public Health, voted “no” on the delay, saying the data aren’t conclusive in either direction. “We do patients some potential benefit here if this agent is used constructively and intelligently while we wait for additional data,” he said.

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