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Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO ...
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Fusion42 · 31 August 2026 · Fusion42 review
Karyopharm has submitted a supplemental New Drug Application to the FDA for accelerated approval of XPOVIO (selinexor) combined with ruxolitinib for treating myelofibrosis, requesting priority review. The application is supported by Phase 3 SENTRY trial data showing significant spleen volume reduction and promising overall survival signals.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You can now plan product development assuming XPOVIO might gain faster FDA approval for myelofibrosis, creating competitive pressure to address this indication. The priority review path accelerates market entry but demands focus on confirmatory survival data.
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1 source · 31 Aug 2026
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