Karyopharm Therapeutics submitted a supplemental New Drug Application to the FDA seeking Accelerated Approval for XPOVIO (selinexor) combined with ruxolitinib in patients with myelofibrosis and requested Priority Review. If granted, Priority Review could lead to a six-month review. The filing is based in part on Phase 3 SENTRY data, including spleen responses and a promising overall survival signal. Accelerated Approval would require the FDA to accept spleen volume reduction of at least 35% as a surrogate reasonably likely to predict overall survival. Karyopharm plans to use long-term SENTRY survival data to verify clinical benefit and seek conversion to traditional approval. The company expects an FDA filing-acceptance decision and potential review timeline in the fourth quarter of 2026.