The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional approval for selinexor in combination with dexamethasone for the treatment of adult myeloma patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on marketing authorization application (MAA). An EC marketing authorisation through the centralised procedure is valid in all 27 European Union member countries as well as the European Economic Area countries Iceland, Liechtenstein and Norway.
The MAA is supported by data from the phase 2b STORM study which evaluated selinexor in patients with heavily pretreated, triple class refractory myeloma
For the study’s primary endpoint, oral selinexor achieved an overall response rate of 26% (95% confidence interval [CI], 19, 35) and the trial therefore met its primary endpoint.
Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound that is approved the United States Food and Drug Administration (FDA) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. During the American Society of Hematology (ASH) Annual Meeting in December 2019 Myeloma Patients Europe (MPE) interviewed Dr Cristina Gasparetto, Duke Cancer Institute, North Corolina, USA, to understand the mechanism of action of this drug.