Karyopharm announces FDA meeting to review selinexor data

Karyopharm announced that the Oncologic Drugs Advisory Committee, or ODAC, of the FDA is scheduled to review data supporting the company’s new drug application, or NDA, requesting accelerated approval for selinexor, an oral selective inhibitor of nuclear export, or SINE, compound, at a meeting. The proposed indication to be discussed at this upcoming ODAC meeting is for selinexor in combination with dexamethasone for the treatment of patients with refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, or PI, one immunomodulatory agent, or IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. The company has also submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for selinexor requesting conditional approval for the treatment of patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. The selinexor MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.

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