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 SIENDO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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.
Read Announcement- Drug:
- Selinexor
- Announced Date:
- April 24, 2024
- Indication:
- Myelofibrosis
Announcement
Karyopharm Therapeutics Inc. announced that several abstracts detailing new selinexor data have been selected for presentation at the 2024 American Society of Clinical Oncology Annual Meeting (2024 ASCO Annual Meeting) being held May 31 - June 4 in Chicago, IL.
AI Summary
Karyopharm Therapeutics Inc. announced that several new abstracts on selinexor data have been selected for presentation at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, which will take place from May 31 to June 4. This is an important opportunity for the company as it plans to share updated findings on its use of selinexor, particularly in the treatment of endometrial cancer. Notably, one presentation, part of the “ASCO Plenary Series: Rapid Abstract Updates,” will highlight long-term follow-up results from a subgroup analysis in advanced or recurrent endometrial cancer patients with TP53 wild-type tumors. The data support ongoing efforts to demonstrate the long-term benefits of selinexor in this challenging area of unmet medical need, further reinforcing its position as a novel treatment option in cancer therapy.
Read Announcement
SIENDO (selinexor) - FDA Regulatory Timeline and Events
SIENDO (selinexor) is a drug developed by Karyopharm Therapeutics for the following indication: Endometrial Cancer.
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:
- SIENDO (selinexor)
- Announced Date:
- June 1, 2024
- Indication:
- Endometrial Cancer
Announcement
Karyopharm Therapeutics Inc. announced the presentation of updated exploratory subgroup analyses from the SIENDO study (NCT03555422), in patients with advanced or recurrent TP53 wild-type endometrial cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Karyopharm Therapeutics recently announced updated exploratory subgroup analyses from its SIENDO study, which were presented at the 2024 ASCO Annual Meeting. In this analysis, patients with advanced or recurrent TP53 wild‐type endometrial cancer received selinexor as a maintenance therapy after first-line platinum-based chemotherapy. The findings showed promising improvements in progression-free survival (PFS); selinexor-treated patients had a median PFS of 28.4 months compared to 5.2 months on placebo. Notably, in patients with both TP53 wild-type and proficient mismatch repair (pMMR) status, the median PFS extended to 39.5 months. Additionally, a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis indicated an improvement, with selinexor patients experiencing about 11 more months of benefit compared to placebo. These results suggest that selinexor might offer significant advantages as a maintenance therapy for this patient subgroup, meriting further investigation in ongoing studies.
Read Announcement
