FDA experts turn thumbs down on Karyopharm’s troubled pitch for an accelerated OK — but not all of them
The Karyopharm team $KPTI took on a tough challenge on Tuesday, trying to overcome an overwhelmingly critical review by FDA regulators in winning over a panel of outside experts brought in to review their pitch for an accelerated approval of selinexor for multiple myeloma.
They lost, but nevertheless found considerable support for this drug among the panelists.
The panel voted 8 to 5 against an approval, saying affirmatively that the FDA should take a wait-and-see attitude until the randomized pivotal study wraps toward the end of the year.
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