Karyopharm Therapeutics To Submit FDA Supplemental New Drug Application In August 2026 For Accelerated Approval Of Selinexor In Combination With Ruxolitinib To Treat Myelofibrosis

Benzinga · 2d ago

– Following FDA Engagements, Company Plans to Submit sNDA under Accelerated Approval Based Upon Compelling SVR35 Data and Preliminary Overall Survival Data Observed at the Time of the Topline Results –

– Company Plans to Use Long-Term Overall Survival Data from the Ongoing Phase 3 SENTRY Trial to Verify Clinical Benefit –

– If Approved, Selinexor in Combination with Ruxolitinib has the Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis, Adding a Novel Class of Therapy –