PR Newswire Clinical TrialsOriginal article
Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway
NDA FilingSelinexor Plus RuxolitinibPositive
AI Analysis
Summary
Karyopharm plans to submit a supplemental NDA for Selinexor plus Ruxolitinib in myelofibrosis in August 2026 under the Accelerated Approval pathway, with a request for Priority Review, based on compelling SVR35 data and preliminary overall survival data.
Clinical Trial Data
Primary Endpoint
Met
Outcome Details
Company plans to submit sNDA under Accelerated Approval pathway based on SVR35 data and preliminary overall survival data
Importance:7/10
Sentiment:
0.70
Accelerated ApprovalPriority ReviewsNDAMyelofibrosisSVR35
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Published by PR Newswire Clinical Trials on July 30, 2026 8:06 PM