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Karyopharm Selinexor Approval Likely Awaits BOSTON Trial, But US FDA Promises To Move Quickly

 
• By Michael McCaughan

Oncologic Drugs Advisory Committee says Karyopharm’s multiple myeloma therapy is not ready for approval based on a single arm study. US FDA says it will move quickly when randomized trial is done.  

FDA entrance sign 2016

The approvability of Karyopharm’s selinexor will likely hinge on the results of an ongoing randomized trial after a majority of the US FDA’s Oncologic Drugs Advisory Committee agreed that the agency should not approve the drug based on existing data from a single-arm study in a highly refractory multiple myeloma population.

The committee voted 8-5 that approval of the drug should await the ongoing BOSTON trial. The minority vote in favor of immediate approval will probably not persuade the agency, given the reservations expressed by FDA in its pre-meeting

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