Following the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), the European Commission now grants conditional marketing authorization for selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM).1 Patients eligible for treatment with this combination have received at least four lines of therapy, are refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and their disease has progressed with the last therapy.
Selinexor is a first-in-class selective inhibitor of nuclear export (SINE) therapy that binds and blocks the function of nuclear export protein exportin 1. This action prevents the export of tumor suppressor proteins from the nucleus, leading to an increased concentration and therefore enhanced anti-tumor activity.
The decision for granting conditional marketing authorization follows the results of the phase II STORM study (NCT02336815). In this trial, 123 patients were enrolled and treated with oral selinexor. All patients had received a median of seven previous lines of therapy and had triple-class refractory MM. An overall response rate of 26% was achieved in this cohort of heavily pretreated patients. The median overall survival was 8.6 months in the total population and 15.6 months in patients who achieved a minimal response or better. Serious adverse events were recorded in 58% of patients and 9% experienced a fatal adverse reaction.
Selinexor with dexamethasone received U.S. Food and Drug Administration (FDA) approval in 2019, the details of which can be found here.