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Positive opinion from EMA’s CHMP on selinexor with dexamethasone for patients with refractory multiple myeloma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced a positive opinion regarding the use of the combination of selinexor and dexamethasone to treat adult patients with multiple myeloma (MM).1 This combination is for patients who have been treated with ≥ 4 previous therapies or are refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who demonstrated progressive disease on the last therapy.
A positive opinion from the CHMP acts as a recommendation for marketing authorization and is one of the last steps before the European Commission makes a decision with respect to the marketing authorization application (MAA) for selinexor.
Data from the phase IIb STORM study (NCT02336815) was used to support this decision. This trial evaluated selinexor + dexamethasone in patients with heavily pretreated, triple-class refractory MM. The study met its primary endpoint as it achieved an overall response rate of 26% (95% CI, 19–35). The median overall survival (OS) was 8.6 months in the total population. The patients who achieved at least a minimal response or better, had an OS of 15.6 months.2 More information on this trial can be found here.
Selinexor is a first-in-class oral selective inhibitor of nuclear export (SINE) compound that binds to and blocks exportin 1. This leads to the accumulation of tumor suppressor proteins among others and enhances their action within the cell. Selinexor with dexamethasone received the U.S. Food and Drug Administration (FDA) approval in 2019, and the details can be found here.
A second EMA regulatory filing is planned for selinexor in combination with bortezomib and dexamethasone for patients with MM with at least one prior line of therapy. This application is supported by the results of the phase III BOSTON trial (NCT03110562), and the application is expected to be submitted by April 2021.
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