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FEBRUARY 28, 2019

FDA Advisory Committee Rejects Selinexor for MM, Wants More Data

By SPC News Staff

The FDA Oncologic Drugs Advisory Committee (ODAC) voted against a recommendation for selinexor (Karyopharm Therapeutics), which is seeking an indication for patients with relapsed-refractory multiple myeloma, because committee members could not decide whether the benefits outweighed the risks.

Selinexor is a first-in-class, oral selective inhibitor of nuclear export (or SINE) compound. Selinexor works by binding with and inhibiting the nuclear export protein XPO1 (also called