FDA Places Partial Clinical Hold on Karyopharm’s Selinexor Trials
The FDA placed a partial clinical hold on Karyopharma’s clinical trials of selinexor — an oral selective inhibitor of nuclear export.
The clinical hold pauses enrollment in selinexor clinical trials, but allows patients with a stabilized disease to remain on the drug candidate. The FDA issued the hold due to incomplete information in Karyopharma’s version of the investigator's brochure (IB), the company said.
The company has amended the brochure to update the informed consent documents and submitted the revised documents to the FDA. The partial hold is not associated with safety concerns, Karyopharma said.