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Karyopharm, 골수섬유증에서 selinexor + ruxolitinib에 대한 8월 sNDA 계획
The company remains on track for an August 2026 sNDA submission under the Accelerated Approval pathway for selinexor plus ruxolitinib in myelofibrosis, following FDA feedback that SVR35 qualifies as a reasonably likely surrogate endpoint. The filing is supported by Phase 3 SENTRY data presented at ASCO/EHA and published in JCO. If approved, this would be the first approved combination therapy for myelofibrosis.
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출처 발췌
EX-99.1 2 kpti-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission – Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track – – Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis – – Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 – – Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130 Mil
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2026년 6월 2일
PM 02:02
KPTI카리오팜Karyopharm SENTRY 3상 selinexor+ruxolitinib, EHA 2026 late-breaking oral 발표 선정