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Oncologic Drugs Advisory Committee

On Tuesday, February 26, 2019, the Oncologic Drugs Advisory Committee (ODAC) held a half-day (afternoon) meeting to discuss a new drug application (NDA) for selinexor tablets, application submitted by Karyopharm Therapeutics, Inc. (Karyopharm), for use, in combination with dexamethasone, in the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

A majority of the committee, eight of 13 members, voted to recommend delaying selinexor’s approval until results of an ongoing, randomized phase 3 trial, named BOSTON, become available.