Karyopharm files sNDA seeking FDA approval for myelofibrosis combo

Karyopharm Therapeutics (Nasdaq: KPTI) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis, according to a company statement.

The company has also requested Priority Review of the application, which, if granted, could result in a six-month review process. Karyopharm expects to receive notice of the FDA's filing acceptance decision in the fourth quarter of 2026, following the agency's standard 60-day filing review period.

The sNDA is based in part on data from the Phase 3 SENTRY trial. Karyopharm stated it believes the data supports a positive benefit-risk profile for the combination, including a signal of overall survival. Accelerated Approval under this pathway would require the FDA to agree that spleen volume reduction of 35% or greater serves as a reasonably likely surrogate endpoint to predict overall survival.

Karyopharm plans to use long-term overall survival data from the SENTRY trial to verify clinical benefit and support conversion from accelerated to traditional approval. The company said it expects to continue working with the FDA during its review to finalize a confirmatory evidence plan.

Selinexor previously received Orphan Drug Designation from the FDA in May 2022 for myelofibrosis treatment, and the European Commission granted Orphan Medicinal Product Designation in October 2022. The FDA also granted Fast Track Designation for selinexor in myelofibrosis in July 2023.

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