Karyopharm to file myelofibrosis drug application in August 2026
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Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway
July 30, 2026 4:06 PM EDTCompany Plans to Submit sNDA in August 2026 and Will Request Priority Review
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... More
