Additional Relevant Details
The FDA has indicated that the partial clinical hold is due to incomplete information in the existing version of the investigator's brochure (IB), including an incomplete list of serious adverse events (SAEs) associated with selinexor. At the FDA's request, Karyopharm has amended the IB and updated the informed consent documents accordingly and has submitted such documents to the FDA as requested. The partial clinical hold is not the result of any patient death or any new information regarding the safety profile of selinexor.  To date, more than 1,900 patients have been treated with selinexor in clinical trials across a variety of hematological and solid tumor malignancies.