Selinexor regulatory update

Karyopharm said FDA placed a partial clinical hold on trials evaluating selinexor due to incomplete information, including an incomplete list of serious adverse events, in the investigator's brochure for the candidate. The company said it submitted an amended version to FDA. Under the hold, no new patients may be enrolled in ongoing trials of selinexor, but patients “with stable disease or better” may remain on the oral selective inhibitor of nuclear export (SINE) protein exportin 1 (XPO1; CRM1). The company expects FDA to notify it within 30 days whether it has lifted the hold and said it believes timelines for ongoing trials will be unaffected...