Karyopharm Therapeutics has alerted investors that the FDA has put a partial hold on all studies involving lead cancer drug, selinexor.
The agency cited incomplete information in the investigator’s brochure on the drug, which included an incomplete list of the adverse events.
The partial hold means patients with stable disease or better may remain on selinexor therapy, but new patients may be enrolled until the hold is lifted.
As of March 10, 2017, Karyopharm provided all requested materials to the FDA in order to lift the partial clinical hold. The FDA has 30 days from receipt of Karyopharm’s submission to notify the company whether the partial clinical hold is lifted.
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