Hematology
Karyopharm Submits FDA Application for Selinexor Plus Ruxolitinib in Myelofibrosis

Karyopharm Submits FDA Application for Selinexor Plus Ruxolitinib in Myelofibrosis

Vahe Grigoryan By Vahe Grigoryan, MD, Editorial Director at OncoDaily Aug 31, 2026
Nare Hovhannisyan Fact checked by Nare Hovhannisyan, MD, Content Creator and Medical Writer at OncoDaily
Elen Baloyan Medically reviewed by Elen Baloyan, MD, Medical Oncologist, Managing Editor of OncoDaily

Karyopharm Therapeutics has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis.

The company has also requested Priority Review, which, if granted, could shorten the FDA review period to approximately six months.

If approved, selinexor plus ruxolitinib could become the first approved combination therapy for patients with myelofibrosis, according to Karyopharm.

Submission Supported by Phase 3 SENTRY Trial

The regulatory submission is supported in part by findings from the Phase 3 SENTRY trial (XPORT-MF-034; NCT04562389), which evaluated once-weekly selinexor plus ruxolitinib against placebo plus ruxolitinib in 353 patients with JAK inhibitor-naïve myelofibrosis.

At Week 24, 49.8% of patients receiving selinexor plus ruxolitinib achieved a spleen volume reduction of at least 35% (SVR35) compared with 28.0% of patients receiving ruxolitinib alone, meeting one of the trial’s co-primary endpoints.

The second co-primary endpoint, improvement in total symptom score, was not met, with symptom improvement observed in both treatment groups without a significant between-group difference.

An early overall survival signal was also reported. At approximately 12 months of median follow-up, the hazard ratio for death was 0.43 for selinexor plus ruxolitinib versus ruxolitinib alone, although longer follow-up is required to establish the durability and clinical significance of this finding.

Phase 3 SENTRY: Selinexor + Ruxolitinib Improved Spleen Responses in JAKi-Naïve Myelofibrosis

Ruxolitinib, Selinexor

Accelerated Approval Pathway

Karyopharm is seeking Accelerated Approval based on the potential for SVR35 to serve as a surrogate endpoint reasonably likely to predict overall survival.

If accelerated approval is granted, the company plans to use long-term overall survival data from the ongoing SENTRY trial to confirm clinical benefit and support conversion to traditional FDA approval.

Karyopharm expects to receive the FDA’s decision regarding acceptance of the sNDA for review, as well as the anticipated regulatory timeline, in the fourth quarter of 2026, following the agency’s 60-day filing review period.

Selinexor previously received FDA Orphan Drug Designation for myelofibrosis in May 2022 and Fast Track Designation in July 2023.

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Vahe Grigoryan

Author

Vahe Grigoryan

MD, Editorial Director at OncoDaily

Vahe Grigoryan is a medical doctor and Editorial Director at OncoDaily, and host of the ONCOFFEE podcast. He aspires to pursue a career in oncology and is passionate about cancer medicine, scientific communication, and the people and stories shaping the field. As an Editorial Director at OncoDaily, Vahe develops original medical news and educational content covering advances in cancer research, treatment, policy, and professional development. Through the ONCOFFEE podcast, he speaks with early-career oncologists and healthcare professionals about their journeys, training challenges, and experiences in medicine. His interests include clinical oncology, cancer research, medical education, and making complex scientific information clear and accessible to the global oncology community.
Nare Hovhannisyan
Fact checked by Nare Hovhannisyan MD, Content Creator and Medical Writer at OncoDaily Nare Hovhannisyan, MD, is a radiation oncology resident at Yerevan State Medical University and the National Center of Oncology in Armenia. She is also a content creator and medical writer at OncoDaily, where she develops original articles covering radiotherapy, scientific and clinical research, oncology conferences, public health, professional awards, leadership appointments, and career developments within the global oncology community. Her work at OncoDaily includes reporting key findings from major international congresses, including ESMO, ESTRO, and ASTRO, conducting interviews with oncology professionals, and translating complex medical evidence into clear and accessible content for a professional audience. She collaborates closely with the editorial team to ensure scientific accuracy and evidence-based reporting. Nare previously gained clinical experience in medical oncology at the Mikayelyan Institute of Surgery, participating in chemotherapy administration, toxicity management, supportive care, and multidisciplinary tumour board discussions. Her professional interests include modern radiotherapy techniques, treatment planning, precision oncology, multidisciplinary cancer care, clinical research, and scientific communication. She has participated in several international educational programmes, including the ESMO Preceptorship on Practising Oncology and advanced ESMO courses in antibody–drug conjugates, genitourinary cancers, and precision oncology. She is also a co-author of the abstract “Patterns of Radiotherapy for Lymphoma in Armenia: An Analysis from 2020 to 2023,” published in *Clinical Lymphoma, Myeloma and Leukemia* in 2024.
Elen Baloyan
Medically reviewed by Elen Baloyan MD, Medical Oncologist, Managing Editor of OncoDaily Elen Baloyan is a medical oncologist, the Managing Editor of OncoDaily and the Editor-in-Chief of OncoDaily Magazine. She is a clinical research physician at the Immune Oncology Research Institute, with special focus on immunotherapy, lung cancer and global oncology. She is currently a research fellow at the BG Lab, sponsored by OncoDaily. She also serves as the Vice President of News and Content Strategy of P53 Inc..
FDA Karyopharm myelofibrosis ruxolitinib selinexor XPOVIO