Karyopharm seeks XPOVIO myelofibrosis approval
- Karyopharm submitted an FDA application seeking accelerated approval for XPOVIO plus ruxolitinib in myelofibrosis patients.
- The filing is supported by Phase 3 SENTRY trial data involving 353 JAK inhibitor-naïve patients.
- Karyopharm requested Priority Review, which could reduce the FDA review period to six months if granted.
Karyopharm Therapeutics (NASDAQ:KPTI) submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval for XPOVIO (selinexor) combined with ruxolitinib to treat patients with myelofibrosis.
The application follows Phase 3 SENTRY trial results evaluating the combination in patients who had not previously received JAK inhibitor treatment, with the company seeking a new indication for XPOVIO.
The sNDA is supported by SENTRY data from 353 patients using spleen volume reduction of at least 35% at week 24 and symptom score changes as co-primary endpoints, while Karyopharm plans to use long-term overall survival data as confirmatory evidence.
Karyopharm requested Priority Review for the application, which if granted could shorten the FDA review timeline to six months.
Karyopharm develops cancer treatments focused on targeted therapies, including XPOVIO, which is approved for certain hematologic malignancies.
Selinexor has U.S. and European Union orphan designations for myelofibrosis and a U.S. Fast Track designation, while the company expects FDA filing acceptance and timeline information in the fourth quarter of 2026.
