FDA Receives sNDA for Selinexor Plus Ruxolitinib in JAK Inhibitor–Naive Myelofibrosis

Karyopharm Therapeutics submitted a supplemental New Drug Application (sNDA) to the FDA seeking accelerated approval for selinexor combined with ruxolitinib to treat patients with JAK inhibitor–naive myelofibrosis, supported by positive results from the phase 3 SENTRY trial showing significant spleen volume reduction and an overall survival signal.

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