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Wire · regulatory

FDA sNDA Submission Is Planned for Selinexor Plus Ruxolitinib in Myelofibrosis

31 July 2026 · By · Wire by Fusion42

Published

31 July 2026

Topic

regulatory

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at onclive.com →

◆ Verified

Fusion42 · 31 July 2026 · Fusion42 review

Karyopharm Therapeutics plans an FDA supplemental new drug application submission in August 2026 seeking accelerated approval for selinexor plus ruxolitinib in myelofibrosis based on positive spleen volume reduction data from the phase 3 SENTRY trial.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 31 Jul 2026 and 1 Aug 2026.

◆ ◆ The Wire takeaway

You face a clear opportunity as the FDA is leaning on spleen size reduction as a surrogate for survival in myelofibrosis drug approval. Get ready to position your product claims around this endpoint and track accelerated pathways with priority review incentives.

◆ Coverage

2 sources · first reported 31 Jul 2026 · latest 1 Aug 2026

◆ Related on Wire

◆ Topics

Biotechfdaaccelerated-approvalmyelofibrosisselinexorruxolitinibclinical-trial