Karyopharm plans August sNDA filing seeking FDA priority review for selinexor-ruxolitinib in myelofibrosis - KPTI News | RalliesKaryopharm plans August sNDA filing seeking FDA priority review for selinexor-ruxolitinib in myelofibrosis
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KPTI• Planned FDA filing and review request
- Karyopharm plans to file an sNDA with the FDA in August 2026 for selinexor with ruxolitinib in myelofibrosis.
- The application targets accelerated approval using SVR35 as a surrogate endpoint; the company will seek Priority Review.
- If Priority Review is granted, the PDUFA action date would be about six months from FDA receipt.
