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# Karyopharm sNDA Filed for Xpovio in Myelofibrosis
- URL: https://www.fdaweb.com/karyopharm-snda-filed-for-xpovio-in-myelofibrosis/
- Published: 2026-08-31T12:00:00.000Z
- Updated: 2026-09-14T12:05:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161708

Karyopharm Therapeutics has submitted a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitinib for patients with myelofibrosis. Karyopharm has requested a priority review, which, if granted, could result in a six-month review.

The sNDA is based, in part, on data from the Phase 3 SENTRY trial that the company believes supports a positive benefit-risk profile for the combination, including a promising signal of overall survival. The company expects that approval under the accelerated approval pathway would require FDA to “agree that spleen volume reduction greater than 35% (SVR35) is a reasonably likely surrogate endpoint to predict overall survival.” It plans to use long-term overall survival data from the SENTRY trial to verify clinical benefit and support conversion from accelerated to traditional approval.

Xpovio is described as a first-in-class, oral exportin 1 (XPO1) inhibitor compound for treating cancer. It works by selectively binding to and inhibiting the nuclear export protein XPO1\. The drug is approved in multiple oncology indications, including: (**1**) in combination with Velcade (bortezomib) and dexamethasone in adult patients with multiple myeloma after at least one prior therapy; and (2) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma.

A previous accelerated approval for diffuse large B-cell lymphoma was officially withdrawn in April after the company failed to complete a confirmatory study.