The U.S. Food and Drug Administration has placed a partial hold on clinical trials of the experimental drug selinexor (KPT-330), a XPO1 antagonist, for Acute Myeloid Leukemia (AML) patients.
The trials have been halted by the FDA due to incomplete information in the Investigator’s Brochure (IB), which includes an incomplete list of Serious Adverse Events (SAEs) associated with selinexor. This partial clinical hold placed by the FDA prevents new patients to be enrolled into clinical trials with selinexor. However, patients with stable disease or better may remain on selinexor therapy.
Consequently, at the FDA’s request, Karyopharm, the drug’s manufacturers, have amended the IB and the informed consent documents accordingly. The updated documents were submitted to the FDA on 10th March 2017.
Currently, selinexor is being evaluated in multiple studies in newly diagnosed and relapsed/refractory patients with AML.