General AML

The FDA lifts clinical hold on trials of selinexor in AML

The U.S. Food and Drug Administration (FDA) lifted a partial hold on clinical trials of the experimental drug selinexor (KPT-330), a XPO1 antagonist, for Acute Myeloid Leukemia (AML) patients.

On 14th March 2017, the AML Global Portal (AGP) reported on the partial hold placed on clinical trials of selinexor due incomplete information in the Investigator’s Brochure (IB), which includes an incomplete list of Serious Adverse Events (SAEs) associated with selinexor.  

As a result of the partial clinical hold lift, Karyopharm, the drug’s manufacturers, have said trials in hematologic malignancies can begin to enroll patients again. Currently, selinexor is being evaluated in multiple studies in newly diagnosed and relapsed/refractory patients with AML.

References
  1. GlobeNewswire: U.S. FDA Division of Hematology Products Lifts Partial Clinical Hold on Karyopharm’s Selinexor Clinical Trials. 2017 Mar 30. https://globenewswire.com/news-release/2017/03/30/947011/0/en/U-S-FDA-Division-of-Hematology-Products-Lifts-Partial-Clinical-Hold-on-Karyopharm-s-Selinexor-Clinical-Trials.html [Accessed 2017 Apr 6].