Karyopharm submits sNDA for XPOVIO+ruxolitinib in myelofibrosis; seeks Priority Review

Karyopharm Therapeutics Inc.

On Aug 31, 2026, submitted sNDA to FDA for XPOVIO (selinexor) plus ruxolitinib in myelofibrosis, requesting Priority Review.
FDA decision on filing acceptance and review timelines expected in Q4 2026 after 60-day filing review period.
Submission based on Phase 3 SENTRY trial data, including promising overall survival signal and positive benefit-risk profile.
Accelerated Approval would require FDA to accept SVR35 (spleen volume reduction ≥35%) as surrogate endpoint for overall survival.
Company plans to use long-term SENTRY overall survival data to verify clinical benefit and convert to traditional approval.

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