The US Food and Drug Administration (FDA) has awarded fast track designation to selinexor for the treatment of myeloma patients who have received at least 3 prior treatments, and who are penta-refractory. This designation aims to expedite the review of drugs and give patients earlier access.
This decision is based upon promising results from the Phase IIb trial, STORM, which investigated the efficacy of selinexor in combination with dexamethasone for heavily pre-treated myeloma patients. The results from this trial are expected to be announced soon.
Selinexor is currently being investigated in the UK in combination with bortezomib (Velcade®) and dexamethasone for relapsed and refractory myeloma patients in the Phase III BOSTON trial.