This section highlights FDA-related milestones and regulatory updates for drugs developed by Karyopharm Therapeutics (KPTI).
Over the past two years, Karyopharm Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Selinexor and Selinexor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Selinexor plus ruxolitinib FDA Regulatory Events
Selinexor plus ruxolitinib is a drug developed by Karyopharm Therapeutics for the following indication: Myelofibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Selinexor plus ruxolitinib
- Announced Date:
- June 2, 2026
- Indication:
- Myelofibrosis
Announcement
Karyopharm Therapeutics Inc. will present the results of its Phase 3 SENTRY trial in a late-breaking oral presentation titled: Selinexor plus ruxolitinib in JAK inhibitor-naïve myelofibrosis: Phase 3 SENTRY trial (LBA6500) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting today
AI Summary
Karyopharm Therapeutics said it will present Phase 3 SENTRY trial results today at the 2026 ASCO Annual Meeting in a late-breaking oral session. The study looked at selinexor plus ruxolitinib in patients with myelofibrosis who had not used a JAK inhibitor before. According to the company, the combination led to a fast and nearly doubled rate of patients reaching SVR35 at week 24 compared with ruxolitinib alone, with benefits seen across different patient groups. Symptom improvement was similar in both treatment arms, and symptom reductions were steady across major symptom areas. Karyopharm also reported a hopeful overall survival signal, with more than a 50% lower risk of death and early separation of survival curves. The trial also suggested possible disease modification, with more patients showing at least a 20% drop in VAF by week 24.
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Selinexor FDA Regulatory Timeline and Events
Selinexor is a drug developed by Karyopharm Therapeutics for the following indication: Myelofibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Selinexor
- Announced Date:
- September 10, 2025
- Indication:
- Myelofibrosis
Announcement
Karyopharm Therapeutics Inc. announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients.
AI Summary
Karyopharm Therapeutics announced it has completed enrollment in its pivotal Phase 3 SENTRY trial, testing selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis patients. A total of 353 patients with platelet counts over 100 x 10⁹/L were randomized 2-to-1 to receive weekly 60 mg selinexor or placebo, both alongside the standard ruxolitinib dose.
The co-primary endpoints are the rate of at least 35% spleen volume reduction at 24 weeks and the change in total symptom score over the same period. Top-line data are expected in March 2026, which could support the first approved combination therapy for myelofibrosis.
CEO Richard Paulson highlighted the potential to redefine treatment by adding selinexor to current care, and CMO Reshma Rangwala praised the dedication of patients and partners. Kapila Viges of the MPN Research Foundation also expressed hope that SENTRY’s results will expand options for more patients living with myelofibrosis.
Read Announcement- Drug:
- Selinexor
- Announced Date:
- February 19, 2025
- Indication:
- Myelofibrosis
Announcement
Karyopharm Therapeutics Inc. provided an overview of its key clinical development programs.
AI Summary
Karyopharm Therapeutics Inc. recently provided an overview of its key clinical development programs. The company is focusing on transforming treatment for myelofibrosis with its Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in patients who have not yet received JAK inhibitors. Enrollment for this trial is expected to complete in the first half of 2025, with top-line results anticipated by the second half of 2025.
In addition, Karyopharm updated its plans for the Phase 3 XPORT-EC-042 trial in advanced or recurrent TP53 wild-type endometrial cancer. After discussions with the FDA and considering the evolving treatment landscape, the trial will primarily focus on patients with proficient mismatch repair (pMMR) tumors or those with deficient mismatch repair (dMMR) who cannot use checkpoint inhibitors. The sample size has been increased to ensure effective evaluation, with data expected in mid-2026.
Read Announcement- Drug:
- Selinexor
- Announced Date:
- January 13, 2025
- Indication:
- Myelofibrosis
Announcement
Karyopharm Therapeutics Inc provided outlined its 2024 achievements and 2025 objectives..
AI Summary
Karyopharm Therapeutics Inc. outlined its major 2024 achievements and set ambitious objectives for 2025. The company’s top strategic goal is to redefine the treatment standard for myelofibrosis. In its Phase 3 SENTRY trial, Karyopharm is evaluating selinexor in combination with ruxolitinib in JAK inhibitor-naïve myelofibrosis patients, with top-line data expected in the second half of 2025. The trial plans to enroll approximately 350 patients, with completion of enrollment targeted for the first half of 2025. This approach aims to demonstrate the benefits of an all-oral combination therapy in improving key outcomes, including spleen volume reduction and symptom score improvement.
Additionally, the company highlighted a robust financial performance in 2024 and announced strategic leadership changes, including appointments for a new Chief Financial Officer and a Senior Vice President of Investor Relations and Corporate Communications, reinforcing its strong commercialization capabilities.
Read Announcement- Drug:
- Selinexor
- Announced Date:
- November 18, 2024
- Indication:
- Myelofibrosis
Announcement
Karyopharm Therapeutics Inc. nnounced abstracts detailing selinexor data have been selected to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2024 in San Diego, CA.
AI Summary
Karyopharm Therapeutics Inc. announced that abstracts detailing selinexor data have been selected to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The event is set for December 7-10, 2024, in San Diego, California. These presentations include key studies on selinexor’s use in treating multiple myeloma and myelofibrosis. One abstract focuses on the efficacy and safety of the selinexor, pomalidomide, and dexamethasone combination in patients with relapsed or refractory multiple myeloma. Another presentation highlights how selinexor, when combined with other therapies, may affect myelofibrosis stem cells by inducing apoptosis and reducing inflammation. The announcement underscores Karyopharm’s ongoing commitment and collaboration with its partners to develop effective treatments for these challenging blood cancers.
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