Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway
Karyopharm announced plans to submit a supplemental New Drug Application (sNDA) in August 2026 for selinexor in combination with ruxolitinib for myelofibrosis, seeking accelerated approval based on Phase 3 SENTRY trial data. The FDA confirmed that spleen volume reduction of at least 35% (SVR35) qualifies as a reasonably likely surrogate endpoint to support this pathway, with long-term overall survival data to be used for verification.
Key figures
- Dosage
- 60 mg once-weekly
- Trial id
- NCT04562389
- Trial phase
- Phase 3
- Svr35 status
- statistically significant improvement
- Patient count
- 353
- Randomization ratio
- 2-to-1
- Pdualf duration months
- approximately six months
- Planned submission month
- August 2026
AI analysis
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