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 Priority Review request, based on compelling SVR35 data and preliminary overall survival data observed in topline results.

Clinical Trial Data

Primary Endpoint

Met

Outcome Details

sNDA submission planned under Accelerated Approval Pathway based on compelling SVR35 data and preliminary overall survival data

Importance:7/10

Sentiment:

0.70

myelofibrosisaccelerated approvalsNDApriority reviewselinexorruxolitinib

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Published by PR Newswire Biotech on July 30, 2026 8:06 PM

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