Karyopharm seeks FDA accelerated approval for Xpovio-ruxolitinib combo in myelofibrosis - KPTI News | RalliesKaryopharm seeks FDA accelerated approval for Xpovio-ruxolitinib combo in myelofibrosis
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KPTI• FDA filing for Xpovio-ruxolitinib in myelofibrosis
- Karyopharm filed an FDA sNDA seeking accelerated approval for XPOVIO (selinexor) with ruxolitinib in myelofibrosis.
- Priority Review requested, implying a potential six-month review if granted.
- Filing decision, including review timelines, expected in Q4 2026 following the FDA’s 60-day acceptance review.
