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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·07/30/2026 20:11:18
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– 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 –