Selinexor (XPORT-MF-034) - (SENTRY)

Aug. 31, 2026: Karyopharm Therapeutics (NASDAQ: KPTI) said it submitted an sNDA to the FDA seeking Accelerated Approval for XPOVIO (selinexor) plus ruxolitinib in myelofibrosis and requested Priority Review, which could shorten review to six months if granted. The company expects notice on filing acceptance and any review timeline in 4Q 2026 after the FDA’s 60-day filing review.

The application is based in part on the Phase 3 SENTRY trial (XPORT-MF-034; NCT04562389), which evaluated once-weekly selinexor 60 mg plus ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naïve myelofibrosis patients with platelet counts >100 x 10^9/L (N=353), randomized 2:1. Co-primary endpoints were spleen volume reduction of at least 35% at week 24 (SVR35) and average change in absolute total symptom score over 24 weeks.

Karyopharm said the filing relies on SENTRY data supporting a positive benefit-risk profile, including a promising overall survival signal. The company said accelerated approval would require FDA agreement that SVR35 is a reasonably likely surrogate endpoint for overall survival; long-term OS data from SENTRY is planned as confirmatory evidence for potential conversion to traditional approval. SENTRY results were presented at ASCO 2026 and EHA 2026 and published in the Journal of Clinical Oncology.