Drugs / Selinexor
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse large B-cell lymphoma 3 milestones | |||||
| Filed | Other | XPOVIO | diffuse large B-cell lymphoma | 2022-12-23 | “submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Pharmaceutical Administration Bureau of Macau, Malaysian National Pharmaceutical Regulatory Agency and...” antengene.com ↗ “submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Pharmaceutical Administration Bureau of Macau, Malaysian National Pharmaceutical Regulatory Agency” antengene.com ↗ “submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Pharmaceutical Administration Bureau of Macau” antengene.com ↗ |
| Filed | US (FDA) | XPOVIO | diffuse large B-cell lymphoma | 2020-02-19 | “A supplemental New Drug Application was recently accepted by the FDA seeking accelerated approval for selinexor as a new treatment for adult patients with relapsed or...” karyopharm.com ↗ “A supplemental New Drug Application was recently submitted to the FDA seeking accelerated approval for selinexor as a new treatment for patients with relapsed or refractory...” antengene.com ↗ “the FDA accepted supplemental New Drug Application (sNDA) seeking accelerated approval for selinexor as a treatment of adult patients with relapsed or refractory diffuse large...” antengene.com ↗ “A supplemental New Drug Application was submitted to the FDA seeking accelerated approval for selinexor as a new treatment for patients with relapsed or refractory diffuse...” karyopharm.com ↗ |
| Filed | US (FDA) | XPOVIO | diffuse large B-cell lymphoma | 2019-12-23 | “The FDA accepted for filing with Priority Review Karyopharm’s sNDA seeking accelerated approval for selinexor for the treatment of adult patients with relapsed or refractory DLBCL” karyopharm.com ↗ “Karyopharm submitted a sNDA to the FDA in December 2019 requesting accelerated approval for selinexor as a treatment for patients with relapsed or refractory DLBCL” karyopharm.com ↗ |
| Filed high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement 1 milestone | |||||
| Filed | Other | XPOVIO | high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement | 2021-05-06 | “Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in five Asia Pacific markets including mainland China, Australia, South Korea, Singapore and Hong Kong,” antengene.com ↗ “Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore,” antengene.com ↗ “Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore” antengene.com ↗ “filed for regulatory approval of selinexor in both multiple myeloma and DLBCL indications in Australia , Singapore and South Korea in December 2020 .” karyopharm.com ↗ “it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor” antengene.com ↗ “Antengene submitted NDAs for selinexor in Australia, Korea, Singapore and Hong Kong” antengene.com ↗ “Moreover, Antengene has completed an NDA submission for XPOVIO® in Indonesia.” antengene.com ↗ “In Q4 2022, Antengene also submitted NDAs for XPOVIO ® in Malaysia” antengene.com ↗ |
| Filed plasma cell myeloma 6 milestones | |||||
| Filed | Other | XPOVIO | plasma cell myeloma | 2022-12-23 | “submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Pharmaceutical Administration Bureau of Macau, Malaysian National Pharmaceutical Regulatory Agency and...” antengene.com ↗ “submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Pharmaceutical Administration Bureau of Macau, Malaysian National Pharmaceutical Regulatory Agency” antengene.com ↗ “submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Pharmaceutical Administration Bureau of Macau” antengene.com ↗ |
| Filed | EU (EMA) | XPOVIO | plasma cell myeloma | 2020-12-07 | “A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor (XPOVIO ® )” antengene.com ↗ “submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor” karyopharm.com ↗ |
| Filed | US (FDA) | XPOVIO | plasma cell myeloma | 2020-05-20 | “The sNDA requesting approval for XPOVIO as a new, second line treatment for patients with multiple myeloma has now been submitted to the FDA” karyopharm.com ↗ |
| Filed | EU (EMA) | — | plasma cell myeloma | 2020-02-24 | “Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor.” karyopharm.com ↗ “The European Marketing Authorization Application (MAA) of selinexor has been submitted to the European Medicines Agency (EMA).” antengene.com ↗ “A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency.” karyopharm.com ↗ |
| Filed | EU (EMA) | NEXPOVIO | plasma cell myeloma | 2019-01-08 | “European Medicines Agency validated the Marketing Authorization Application (MAA) for NEXPOVIO ® (selinexor) in combination with Velcade® (bortezomib) and low-dose...” karyopharm.com ↗ “MAA to the EMA requesting conditional approval for selinexor, in combination with dexamethasone, as a new treatment for patients with heavily pretreated multiple myeloma” karyopharm.com ↗ “MAA to the EMA requesting conditional approval for selinexor in combination with dexamethasone as a new treatment for patients with heavily pretreated multiple myeloma” karyopharm.com ↗ “Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor.” karyopharm.com ↗ “A Marketing Authorization Application for NEXPOVIO for patients with penta-refractory multiple myeloma is also currently under review by the European Medicines Agency” karyopharm.com ↗ “Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor.” karyopharm.com ↗ “The Company has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) requesting conditional approval for selinexor” karyopharm.com ↗ “A Marketing Authorization Application (MAA) seeking conditional approval for selinexor is currently under review by the European Medicines Agency” karyopharm.com ↗ “today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for selinexor” karyopharm.com ↗ “A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency (EMA).” karyopharm.com ↗ “On January 8, 2019 , Karyopharm submitted a MAA to the EMA requesting conditional approval for selinexor” karyopharm.com ↗ “In January 2019 , Karyopharm submitted an MAA to the EMA requesting conditional approval for selinexor” karyopharm.com ↗ “In January 2019, Karyopharm submitted an MAA to the EMA requesting conditional approval for selinexor” karyopharm.com ↗ “A MAA was submitted to the EMA on January 8, 2019 for selinexor” karyopharm.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | 2018-10-05 | “the U.S. Food and Drug Administration accepted for filing with Priority Review our first New Drug Application seeking accelerated approval for our lead candidate, selinexor” karyopharm.com ↗ “On October 5, 2018 , the FDA accepted for filing with Priority Review Karyopharm’s NDA seeking accelerated approval for selinexor” karyopharm.com ↗ “FDA has accepted for filing with Priority Review its New Drug Application (NDA) seeking accelerated approval for selinexor” karyopharm.com ↗ “In October 2018 , the U.S. FDA accepted Karyopharm’s New Drug Application for selinexor seeking accelerated approval” karyopharm.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | EU (EMA) | XPOVIO | relapsed/refractory diffuse large B-cell lymphoma | — | “Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor.” karyopharm.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (3) | US (FDA) | XPOVIO | — | 2020-06-22 – 2026-04-23 | fda.gov ↗ |
| Approved | EU (EMA) | Nexpovio | — | 2021-03-26 | europa.eu ↗ |
| Filed | China (NMPA) | — | — | 2021-01 | “Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in five Asia Pacific markets including mainland China, Australia, South Korea, Singapore and Hong Kong,” antengene.com ↗ “Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore,” antengene.com ↗ “Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore” antengene.com ↗ “Antengene has submitted a new drug application (NDA) for selinexor to the National Medical Products Administration (NMPA) in January 2021” antengene.com ↗ “Antengene has submitted new drug applications (NDAs) for selinexor in China and multiple APAC markets,” antengene.com ↗ |
| Approved | US (FDA) | XPOVIO | — | 2019-07-03 | fda.gov ↗ |
| Clinical hold | US (FDA) | — | — | 2017-03-10 | “the U.S. Food and Drug Administration (FDA) that its clinical trials for selinexor (KPT-330) have been placed on partial clinical hold.” karyopharm.com ↗ |
Trials 180 · started per year
today
US approved 2019
EU approved 2021
1
22
21
5
5
7
4
11
21
15
20
17
17
12
20122013201420152016201720182019202020212022202320242025202620272028
News releases announcing trial results or a regulatory action · 173
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Antengene Corporation | Results Antengene Publishes Preclinical Research Paper on CD73 Small Molecule Inhibitor ATG‑037 Combined with Selinexor in Cancer Gene Therapy antengene.com ↗
Selinexor treatment was found to upregulate CD73 expression in the majority of tumors, a resistance-associated mechanism that the combination approach was designed to counter. |
| 2026-08-31 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis karyopharm.com ↗
The sNDA submitted is based, in part, on data from the SENTRY trial that the Company believes supports a positive benefit-risk profile for the combination, including a promising signal of overall survival. |
| 2026-07-30 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Topline Results from Phase 3 XPORT-EC-042 Trial in Endometrial Cancer karyopharm.com ↗
The trial did not meet its primary endpoint of progression free survival. |
| 2026-06-14 | Menarini Group | Results Menarini Group Reports Data from the Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis at The European Hematology Association (EHA) 2026 Congress menarini.com ↗
The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24. |
| 2026-06-02 | Karyopharm Therapeutics Inc | Results Karyopharm's Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis Selected for Late-Breaking Oral Presentation at EHA 2026 karyopharm.com ↗
New Data will Highlight a Post-Hoc Analysis from Phase 1 Portion of SENTRY Trial that Indicates Achievement of SVR35 with Selinexor plus Ruxolitinib May Predict Overall Survival |
| 2026-06-02 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Results from Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis in Late-Breaking Oral Presentation at ASCO 2026 with Simultaneous Publication in the Journal of Clinical Oncology karyopharm.com ↗
Selinexor in Combination with Ruxolitinib Demonstrated a Rapid and Near Doubling of Patients Achieving SVR35 at Week 24, versus Ruxolitinib, with a Consistent SVR35 Benefit Observed Across Prespecified Subgroups |
| 2026-03-24 | Karyopharm Therapeutics Inc | Results Karyopharm's Phase 3 SENTRY Trial in Myelofibrosis Met First Co-Primary Endpoint, Demonstrating Statistically Significant Improvement in Spleen Volume Reduction karyopharm.com ↗ |
| 2026-03-02 | Antengene Corporation | Regulatory XPOVIO® Receives Reimbursement Approval in South Korea for a Second Multiple Myeloma Indication antengene.com ↗
This marks the second XPOVIO ® indication to be approved for reimbursement in South Korea. |
| 2025-12-17 | Antengene Corporation | Regulatory Antengene Expands XPOVIO® Indications in Malaysia with Approval in Diffuse Large B-cell Lymphoma antengene.com ↗
With this recent approval, XPOVIO® has further expanded its portfolio of approved indications in Malaysia, bringing the total to three indications across multiple myeloma (MM) and DLBCL, two major therapeutic areas in hematology. |
| 2025-12-03 | Antengene Corporation | Regulatory XPOVIO® Approved in Hong Kong for Two Additional Indications in Multiple Myeloma and Diffuse Large B-Cell Lymphoma antengene.com ↗
XPOVIO® (selinexor) has received approvals for three indications in Hong Kong. |
| 2025-07-28 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Approved in China for the Second-Line Treatment of Multiple Myeloma, Marking the Third Approved Indication of the Drug antengene.com ↗
This approval for XPOVIO® in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy marks the third approved indication of the drug in China. |
| 2025-05-14 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Poster Presentation on Selinexor in Myelofibrosis at the 2025 European Hematology Association Annual Meeting karyopharm.com ↗
Data from the XPORT-MF-035 (NCT04562870) Phase 2, randomized, open-label trial of selinexor versus physician's-choice (PC) in hard-to-treat patients with heavily pretreated myelofibrosis indicated signs of single-agent clinical activity with selinexor, including spleen volume reduction, hemoglobin stabilization, symptom improvement and evidence of disease modification. |
| 2025-05-12 | Karyopharm Therapeutics Inc | Results Karyopharm Reports First Quarter 2025 Financial Results and Announces New Data in Myelofibrosis that Further Suggests Selinexor May Lead to Meaningful Spleen Volume Reduction, Symptom Improvement, Hemoglobin Stabilization and Disease Modification karyopharm.com ↗ |
| 2025-03-05 | Antengene Corporation | Regulatory XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene’s Commercial Presence in APAC antengene.com ↗ |
| 2025-02-13 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Approved for Public Health Insurance Coverage in Taiwan Market, Benefiting More Patients with R/R MM in the Region antengene.com ↗
Starting from March 1, 2025, XPOVIO® will be officially included in the NHI drug reimbursement scheme. |
| 2024-12-10 | Antengene Corporation | Results Antengene Presents Results from Two Late-Stage Clinical Studies of Selinexor at ASH 2024 antengene.com ↗
Efficacy results showed that the median progression-free survival (mPFS) was 8.1 months with SVd group and 6.3 months with Vd group. |
| 2024-11-28 | Antengene Corporation | Regulatory Antengene Announces XPOVIO®’s New Indication Included in 2024 China National Reimbursement Drug List, Making the Drug More Accessible to DLBCL Patients in the Country antengene.com ↗
To date, the two approved indications of XPOVIO ® in China have both been adopted by the NRDL, allowing a growing population of patients to benefit from the drug. |
| 2024-10-18 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® (selinexor) Approved for Its Third Indication in South Korea, Bringing Fresh Hope to Patients with MM in the Country antengene.com ↗
This approval for XPOVIO ® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South Korea. |
| 2024-09-23 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® (selinexor) Approved for Commercialization in Thailand antengene.com ↗
XPOVIO® is the first and only approved XPO1 inhibitor in Thailand. |
| 2024-08-06 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® (selinexor) Approved for Commercialization in Malaysia antengene.com ↗
This successful approval for XPOVIO® in Malaysia will introduce novel therapies to the clinical management of patients with MM in Malaysia, benefiting many patients and their families in the country. |
| 2024-07-05 | Antengene Corporation | Regulatory XPOVIO® (selinexor) Approved for New Indication in DLBCL in China, Bringing a New Treatment Option to Patients in the Country antengene.com ↗ |
| 2024-06-26 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® (selinexor) National Health Insurance Service Approval for Reimbursement in South Korea antengene.com ↗ |
| 2024-06-01 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer During 2024 ASCO Plenary Series: Rapid Abstract Updates karyopharm.com ↗
However, an exploratory analysis of a pre-specified subgroup of patients with TP53 wild-type endometrial cancer showed a promising efficacy signal. |
| 2023-12-10 | Karyopharm Therapeutics Inc | Results Karyopharm Shares Data at ASH 2023 Showing Strong SVR and TSS Durability Observed from Phase 1 Study of Selinexor 60mg and Ruxolitinib in JAK Inhibitor (JAKi)-Naïve Myelofibrosis Patients, with no SVR or TSS Progressions Observed As of the Data Cutoff(1) karyopharm.com ↗
In addition, all patients who achieved TSS50 at Week 24 remained in response as of the data cut-off. |
| 2023-12-06 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Regulatory Approval in Macau for the Treatment of Relapsed and/or Refractory Multiple Myeloma antengene.com ↗
XPOVIO® (selinexor) is the first and only exportin 1 (XPO1) inhibitor approved in Macau. |
| 2023-11-06 | Karyopharm Therapeutics Inc | Results Karyopharm Announces New Preliminary Data in Overall Survival (OS) in Selinexor-Treated Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer as Part of Pre-Specified Exploratory Subgroup Analysis of the SIENDO Study karyopharm.com ↗
Long-Term Safety and Efficacy Data from SIENDO Study in the TP53 Wild-Type Exploratory Subgroup Showed Signals of Improvement in Overall Survival (OS) Regardless of Mismatched Repair Status (MMR) |
| 2023-08-25 | Antengene Corporation | Results Antengene Announces Interim Financial Results for 2023 with New Clinical Data Highlighting the Growing Value of Its Pipeline antengene.com ↗
Results from the “XPORT-MF-034” study evaluating selinexor in combination with ruxolitinib in treating treatment-naïve myelofibrosis patients show that 91.7% of efficacy evaluable patients and78.6% of intent-to-treat (ITT) patients achieved a 35% or greater spleen volume reduction (SVR35) at week 24. |
| 2023-07-25 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer karyopharm.com ↗
Signal of PFS Improvement in SIENDO for Selinexor-Treated Patients was Observed Only in Subgroup Who are TP53 Wild-Type with a Median Progression-Free Survival of 27.4 Months |
| 2023-07-17 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis. |
| 2023-07-17 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Regulatory Approval in Hong Kong for the Treatment of Relapsed and/or Refractory Multiple Myeloma antengene.com ↗
XPOVIO ® (selinexor) is the first and only XPO1 inhibitor approved in Hong Kong |
| 2023-06-08 | Menarini Group | Results Menarini Group Shares NEXPOVIO® (selinexor) Subgroup Data from BOSTON trial at the European Hematology Association Congress, Highlighting Clinical Potential in Relapsed/Refractory Multiple Myeloma menarini.com ↗
In patients with just one prior line of treatment, median progression-free survival (mPFS) was 21 months for those treated with SVd, versus 10.7 months for those treated with Vd alone (HR 0.62). |
| 2023-06-01 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® plus Bortezomib and Dexamethasone Included for Reimbursement by the PBS in Australia for the Treatment of Relapsed and/or Refractory Multiple Myeloma antengene.com ↗ |
| 2023-05-18 | Antengene Corporation | Regulatory Antengene Announces NDA Submission for XPOVIO® in Indonesia antengene.com ↗
today announced that it has submitted New Drug Applications (NDAs) for XPOVIO ® (selinexor) to the Indonesia National Agency of Drug and Food Control (BPOM) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). |
| 2023-04-18 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at AACR 2023 karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced updated results from the Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389). |
| 2023-02-21 | Menarini Group | Regulatory Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO® (selinexor) menarini.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the United Kingdom's (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing Authorization for NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
| 2023-02-21 | Karyopharm Therapeutics Inc | Regulatory Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO® (selinexor) in Combination with Bortezomib and Dexamethasone for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy karyopharm.com ↗ |
| 2022-12-23 | Antengene Corporation | Regulatory Antengene Announces NDA Submission for XPOVIO® in Macau,China, Malaysia and Thailand for Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-cell Lymphoma antengene.com ↗ |
| 2022-12-12 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at ASH 2022 karyopharm.com ↗
today announced updated results from the Phase 1 portion of its study evaluating the safety and efficacy of once-weekly selinexor in combination with standard dose ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389). |
| 2022-11-03 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress karyopharm.com ↗
Encouraging Data Observed in Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Activity Across Three Key Efficacy Endpoints, and a Generally Manageable Safety Profile with No Dose Limiting Toxicities. |
| 2022-11-03 | Karyopharm Therapeutics Inc | Results Karyopharm Announces New Selinexor Data in Myelofibrosis and Multiple Myeloma to be Presented at ASH 2022 karyopharm.com ↗
The presentations include results from the Phase 1 open-label, dose-escalation study of selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (MF) and data from a subset analysis of the STOMP study in patients with triple-class refractory MM. |
| 2022-11-01 | Menarini Group | Regulatory Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European Commission for Selinexor for the Treatment of Myelofibrosis menarini.com ↗
the European Commission (EC) has granted orphan medicinal product designation for selinexor for the treatment of myelofibrosis (MF). |
| 2022-10-31 | Karyopharm Therapeutics Inc | Regulatory Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European Commission for Selinexor for the Treatment of Myelofibrosis karyopharm.com ↗ |
| 2022-10-24 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Regulatory Approval in Taiwan for the Treatment of Relapsed and/or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma antengene.com ↗ |
| 2022-09-01 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Included for Reimbursement by the PBS in Australia for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma antengene.com ↗
XPOVIO ® is the first of a new class of SINE medicines to be made available to Australian patients with penta-refractory R/R MM on the Pharmaceutical Benefits Scheme (PBS). |
| 2022-07-21 | Menarini Group | Regulatory Karyopharm and Menarini Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy menarini.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy. |
| 2022-07-21 | Karyopharm Therapeutics Inc | Regulatory Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy karyopharm.com ↗
With this approval for the extension of NEXPOVIO®'s indication in the European Union (EU), the conditional marketing authorisation is now converted to a full approval. |
| 2022-05-26 | Karyopharm Therapeutics Inc | Results Karyopharm to Present New Selinexor Data at the 2022 American Society of Clinical Oncology Annual Meeting karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced promising initial data from a Phase 1/2 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and subgroup analyses and molecular classification data from the SIENDO study evaluating selinexor in endometrial cancer. |
| 2022-05-20 | Menarini Group | Regulatory Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma menarini.com ↗
Today’s positive CHMP opinion brings us one step closer to our goal of making NEXPOVIO available to patients globally who may benefit from its novel mechanism of action. |
| 2022-05-20 | Karyopharm Therapeutics Inc | Regulatory Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma karyopharm.com ↗
today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received one to three prior lines of therapy. |
| 2022-03-09 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Approved by the TGA in Australia for the Treatment of Relapsed and/or Refractory Multiple Myeloma and Triple Class-Refractory Multiple Myeloma antengene.com ↗
This approval by the TGA is practice-changing for patients in Australia who have long suffered from MM. |
| 2022-03-01 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Provides U.S. Regulatory Update on Selinexor in Advanced or Recurrent Endometrial Cancer karyopharm.com ↗
During a productive meeting with the FDA, the Company received feedback that the current SIENDO study top-line results are unlikely to support an sNDA approval. |
| 2022-03-01 | Antengene Corporation | Regulatory Antengene Announces XPOVIO® Regulatory Approval in Singapore antengene.com ↗
announced today that XPOVIO ® (selinexor) has been granted approval from the Health Sciences Authority (HSA) in Singapore for three indications: |
| 2022-02-08 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Phase 3 SIENDO Study Meets Primary Endpoint with Statistically Significant Increase in Progression-Free Survival in Patients with Advanced or Recurrent Endometrial Cancer karyopharm.com ↗
The SIENDO study met its primary endpoint of a statistically significant improvement in median progression-free survival (PFS) compared to placebo. |
| 2021-12-20 | Antengene Corporation | Regulatory Antengene Announces NDA Approval by NMPA for XPOVIO®, China’s First XPO1 inhibitor, for the Treatment of Adults with Relapsed or Refractory Multiple Myeloma antengene.com ↗ |
| 2021-12-17 | Karyopharm Therapeutics Inc | Regulatory Karyopharm's Partner Antengene Receives Approval in China for XPOVIO® (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that its partner, Antengene Corporation (Antengene), has been granted conditional approval for marketing by the China National Medical Products Administration (NMPA) for XPOVIO ® (selinexor), a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have received prior therapies and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. |
| 2021-12-11 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Updated Phase 2 Selinexor Data in Patients with Myelofibrosis at the American Society of Hematology 2021 Annual Meeting and Exposition karyopharm.com ↗
Of the ten patients who were on treatment for at least 24 weeks, four (40%) patients achieved SVR of ≥35% and six (60%) patients achieved SVR of ≥25%. |
| 2021-11-19 | Antengene Corporation | Regulatory Antengene Announces IND Approval in China for a Phase I II Study of Selinexor (ATG-010) in Patients with Non-Hodgkin Lymphoma antengene.com ↗
today announced that the China National Medical Products Administration (NMPA) has approved a single-arm dose-finding Phase I/II study |
| 2021-11-04 | Karyopharm Therapeutics Inc | Results Karyopharm Announces New Interim Phase 2 Selinexor Data in Myelofibrosis Selected for Oral Presentation at the American Society of Hematology 2021 Annual Meeting and Exposition karyopharm.com ↗
In addition to spleen responses, there was improvement in anemia status and symptom scores in these patients. |
| 2021-11-02 | Antengene Corporation | Regulatory Antengene Granted IND Approval in China for the Phase Ib Study of ATG-008 (Onatasertib) in Combination with ATG-010 (Selinexor) in Patients with Diffuse Large B-Cell Lymphoma antengene.com ↗
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that China’s National Medical Products Administration (NMPA) has approved an open-label Phase Ib dose-escalation study designed to assess the safety of ATG-008 (onatasertib) in combination with ATG-010 (selinexor) in patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). |
| 2021-08-24 | Antengene Corporation | Regulatory Antengene Announces Approval of the Phase II Study of Selinexor for the Treatment of Myelofibrosis in China antengene.com ↗
today announced that China’s National Medical Products Administration has approved a Phase II study of selinexor (XPOVIO®) for the treatment of patients with myelofibrosis (MF). |
| 2021-07-31 | Antengene Corporation | Regulatory Antengene Announces the Approval of First-in-Class Oral XPO1 Inhibitor Selinexor in South Korea for the Treatment of Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma antengene.com ↗ |
| 2021-07-14 | Antengene Corporation | Regulatory Antengene Submits New Drug Application for Selinexor in Taiwan for the Treatment of Three Indications in Hematologic Malignancies antengene.com ↗
today announced that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor |
| 2021-07-06 | Antengene Corporation | Regulatory Antengene Announces Acceptance of IND Application in China for the Phase II Clinical Trial of Single-Agent Selinexor for the Treatment of Myelofibrosis (MF) antengene.com ↗ |
| 2021-06-04 | Antengene Corporation | Results Antengene Announces Publication of Abstract on XPO1 Inhibitor Selinexor in Relapsed or Refractory Multiple Myeloma at ASCO 2021 and EHA 2021 antengene.com ↗
Data from a planned analysis of the first 60 treated patients with a median follow-up of 9.5 months demonstrates an overall response rate (ORR) of 26.7%. |
| 2021-06-02 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Receives Conditional Marketing Authorization in the United Kingdom (UK) for NEXPOVIO® (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma karyopharm.com ↗ |
| 2021-05-19 | Karyopharm Therapeutics Inc | Results Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the 2021 American Society of Clinical Oncology Annual Meeting karyopharm.com ↗
Once-weekly selinexor was shown in this Phase 1b /2 study to be safely combined with Pomalyst® (pomalidomide) and low-dose dexamethasone (XPd) in patients with heavily pretreated MM. |
| 2021-05-12 | Antengene Corporation | Regulatory Antengene Announces IND Approval in China for a Global Phase III Trial of Selinexor in Advanced or Recurrent Endometrial Cancer antengene.com ↗ |
| 2021-04-29 | Antengene Corporation | Regulatory Antengene Announces XPO1 Inhibitor Selinexor Prescribed for the First Time in the Pilot Zone of Hainan Province and Authorized to be Expanded Beyond the Pilot Zone for Outpatient Treatment antengene.com ↗ |
| 2021-04-26 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces European Medicines Agency's Validation of its Type II Variation Marketing Authorization Application for NEXPOVIO® (selinexor) in Combination with Velcade® (bortezomib) and Dexamethasone for the Treatment of Adult Patients with Multiple Myeloma karyopharm.com ↗
Validation of the application confirms the submission is complete to begin the EMA's review process. |
| 2021-04-22 | Antengene Corporation | Results Treatment with Selinexor in Advanced Liposarcoma Demonstrates Clinically Important Reduction in Pain with Improved HRQoL Outcomes antengene.com ↗ |
| 2021-04-19 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Publication of Health-Related Quality of Life Outcomes from Phase 3 SEAL Study of Selinexor in Advanced Unresectable Dedifferentiated Liposarcoma in Future Oncology karyopharm.com ↗
In addition to meeting its primary endpoint with a statistically significant improvement in progression-free survival (PFS), treatment with selinexor also resulted in improvements in key quality of life parameters as compared to patients treated with placebo, |
| 2021-04-12 | Antengene Corporation | Results Antengene Presented Preclinical Data Demonstrating Potent Synergistic Effect of the Combination of ATG-010 (Selinexor) and ATG-008 (Onatasertib) for the Treatment of Triple-Hit DLBCL antengene.com ↗
Results from this study demonstrated potent in vitro and in vivo anti-tumor efficacy and synergy with the combination of ATG-010 and ATG-008, including strong synergistic activities in the triple-hit DLBCL cell line. |
| 2021-03-29 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Receives Conditional Marketing Authorization from the European Commission for NEXPOVIO® (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma karyopharm.com ↗ |
| 2021-02-24 | Antengene Corporation | Regulatory Antengene Announces NDA for ATG-010 (Selinexor) Granted Priority Review by China’s NMPA antengene.com ↗
ATG-010 is a novel option for the treatment of rrMM and we are pleased that it has been granted priority review by the NMPA. |
| 2021-02-04 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces XPOVIO® (selinexor) Receives Regulatory Approval in Israel for the Treatment of Patients with Multiple Myeloma and Diffuse Large B-Cell Lymphoma karyopharm.com ↗ |
| 2021-01-29 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Receives Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma karyopharm.com ↗
The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on Karyopharm's marketing authorization application (MAA). |
| 2021-01-28 | Antengene Corporation | Regulatory Antengene Announces the Acceptance of ATG-010 (Selinexor) NDA by the NMPA for the Treatment of rrMM antengene.com ↗ |
| 2021-01-25 | Antengene Corporation | Regulatory Antengene Announces Approval of IND Application in China for ATG-010 (Selinexor) in Combination with R-GDP (SR-GDP) for the Treatment of rrDLBCL in a Global Phase 2/3 Study antengene.com ↗ |
| 2021-01-05 | Antengene Corporation | Regulatory Antengene Announces Submission of IND Application in China for a Global Phase 3 Trial of ATG-010 (Selinexor) in Advanced or Recurrent Endometrial Cancer antengene.com ↗
announced that it submitted an Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) for ATG-010 (selinexor) in the treatment of Endometrial Cancer. |
| 2021-01-04 | Antengene Corporation | Regulatory Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL antengene.com ↗
announced that it has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO ® ) |
| 2020-12-21 | Antengene Corporation | Regulatory Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has received FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy antengene.com ↗ |
| 2020-12-18 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy karyopharm.com ↗ |
| 2020-12-11 | Antengene Corporation | Regulatory Antengene Announces Acceptance of IND Application in China for a Phase 3 Clinical Trial of ATG-010 (Selinexor) in Combination with Bortezomib and Dexamethasone (SVd) for the Treatment of rrMM antengene.com ↗ |
| 2020-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Presents XPOVIO® (Selinexor) Data in Multiple Myeloma and Diffuse Large-B-Cell Lymphoma at the American Society of Hematology 2020 Annual Meeting karyopharm.com ↗
The highlights of our ASH data this year include updated data from multiple arms of the STOMP study where once weekly oral XPOVIO continues to demonstrate compelling and durable responses in important patient subgroups when combined with approved multiple myeloma therapies. |
| 2020-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of New XPOVIO® (Selinexor) Data in Patients with Acute Myeloid Leukemia at the American Society of Hematology 2020 Annual Meeting karyopharm.com ↗
The data presented today at ASH 2020, show that XPOVIO in combination with standard induction and consolidation chemotherapy appears highly active in older patients with de novo AML. |
| 2020-12-07 | Antengene Corporation | Regulatory Antengene Announces Acceptance of IND Application in China for ATG-010 (Selinexor) in Combination with R-GDP (SR-GDP) for the Treatment of rrDLBCL in a Global Phase 2/3 Study antengene.com ↗ |
| 2020-12-03 | Antengene Corporation | Regulatory Antengene Submits NDAs for XPOVIO® (Selinexor) in Multiple APAC Markets for rrMM and rrDLBCL antengene.com ↗
Australian Therapeutic Goods Administration has accepted the NDA of Antengene on December 2, 2020. |
| 2020-11-25 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Ongoing Phase 3 SIENDO Study of XPOVIO® (Selinexor) in Patients with Endometrial Cancer Passes Planned Interim Futility Analysis: Data and Safety Monitoring Board Recommends the Study Should Proceed as Planned Without Any Modifications karyopharm.com ↗
We are very excited that the SIENDO study has passed its planned futility analysis and that the study will continue as planned, |
| 2020-11-20 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Positive Phase 3 SEAL Data in Oral Presentation at The Connective Tissue Oncology Society 2020 Annual Meeting karyopharm.com ↗
The data presented at CTOS 2020 demonstrated that patients treated with XPOVIO experienced a statistically significant improvement in median PFS compared to placebo in patients with at least two prior therapies. |
| 2020-11-12 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Publication of XPOVIO® (Selinexor) Phase 3 BOSTON Study Results in The Lancet karyopharm.com ↗ |
| 2020-11-02 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Third Quarter 2020 Financial Results and Highlights Recent Company Progress karyopharm.com ↗ |
| 2020-11-02 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Phase 3 SEAL Study Meets Primary Endpoint with Significant Increase in Progression-Free Survival in Patients with Unresectable Dedifferentiated Liposarcoma karyopharm.com ↗
The SEAL study met its primary endpoint of a statistically significant increase in progression-free survival (PFS); hazard ratio=0.70; p=0.023. |
| 2020-10-06 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Selinexor Clinical Data to be Presented at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19 karyopharm.com ↗
the results demonstrated encouraging anti-viral and anti-inflammatory activity in an important subset of treated patients. |
| 2020-09-14 | Karyopharm Therapeutics Inc | Results Karyopharm Announces XPOVIO® (selinexor) Clinical Data to be Presented at European Society for Medical Oncology Virtual Congress 2020 karyopharm.com ↗
We are particularly encouraged by data from the Phase 1b study of XPOVIO in combination with pembrolizumab, which showed significant clinical activity as frontline therapy compared to historic frontline single-agent pembrolizumab in patients with metastatic non-uveal melanoma. |
| 2020-08-04 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Second Quarter 2020 Financial Results and Highlights Recent Company Progress karyopharm.com ↗
There was also a significant improvement in conversion to SARS-CoV2 PCR negative status on the selinexor arm as compared with the placebo arm across the entire population (p≤0.05). |
| 2020-07-20 | Karyopharm Therapeutics Inc | Regulatory U.S. Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO® (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Line of Therapy karyopharm.com ↗ |
| 2020-06-24 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Publication of XPOVIO® (Selinexor) Phase 2b SADAL Study Results in The Lancet Haematology karyopharm.com ↗
In this population, single-agent oral XPOVIO (selinexor) demonstrated an overall response rate of 28%, including a complete response rate of 12%. |
| 2020-06-22 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces FDA Approval of XPOVIO® (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) karyopharm.com ↗
This approval marks the first for an oral agent for patients with previously treated DLBCL and the first approval of any single drug for this highly aggressive type of lymphoma. |
| 2020-06-12 | Karyopharm Therapeutics Inc | Results Karyopharm Presents XPOVIO® (selinexor) and Eltanexor Data at the European Hematology Association 2020 Virtual Annual Meeting karyopharm.com ↗
demonstrating a 9-month median overall survival in a patient population in which survival is expected to be <6 months based on several historical controls |
| 2020-05-28 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Positive Phase 3 BOSTON Data in Oral Presentation at the American Society of Clinical Oncology 2020 Virtual Scientific Program karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today reported detailed results from the pivotal, Phase 3 BOSTON study to be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program on May 29, 2020 . |
| 2020-05-20 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Submits Supplemental New Drug Application to FDA for XPOVIO® (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Line of Therapy karyopharm.com ↗
today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) |
| 2020-03-03 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Phase 3 BOSTON Study Meets Primary Endpoint with Significant Increase in Progression-Free Survival in Patients with Multiple Myeloma Following One to Three Prior Lines of Therapy karyopharm.com ↗
The BOSTON study met its primary endpoint of a statistically significant increase in progression-free survival (PFS). |
| 2020-03-02 | Antengene Corporation | Results Phase 3 Clinical Study of Novel Selective Inhibitor of Nuclear Export Selinexor with New Combination Therapy for Multiple Myeloma Meets Primary Endpoint antengene.com ↗
The median PFS was 13.93 months in the SVd arm and 9.46 months in the Vd arm, representing a 4.47 month (47%) increase in median PFS (hazard ratio=0.70; p=0.0066). |
| 2020-02-24 | Antengene Corporation | Regulatory Novel oral medication for diffuse large B-cell lymphoma! Another indication of XPOVIO®, a first-in-class nuclear export inhibitor, is expected to achieve accelerated approval antengene.com ↗
Simultaneously, FDA also included this drug in the Priority Review and assigned a user fee goal date of June 23, 2020 under the Prescription Drug User-Fee Act (PDUFA). |
| 2020-02-19 | Karyopharm Therapeutics Inc | Regulatory U.S. Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO® (Selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma karyopharm.com ↗
The FDA also granted Karyopharm’s request for Priority Review and assigned a user fee goal date of June 23, 2020 under the Prescription Drug User-Fee Act (PDUFA). |
| 2020-01-20 | Antengene Corporation | Regulatory News Express! The Clinical Trial of ATG-010 for Peripheral T-cell Lymphoma and NK/T-cell Lymphoma Has Been Approved antengene.com ↗
Antengene announced today that NMPA has approved the clinical trial application of ATG-010 for relapsed or refractory peripheral T and NK/T-cell lymphoma on January 13, 2020. |
| 2019-12-23 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Submits New Drug Application to U.S. FDA for XPOVIO® (selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma karyopharm.com ↗
The submission of this second NDA is a significant achievement for Karyopharm and brings XPOVIO one step closer to serving an entirely new group of patients. |
| 2019-12-08 | Karyopharm Therapeutics Inc | Results Karyopharm Presents XPOVIO® (Selinexor) and Eltanexor Data at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
The Kyprolis arm of the STOMP study continues to show clear signs of clinical activity, including a complete response rate of 21%, in patients with heavily pretreated Kyprolis-naïve multiple myeloma. |
| 2019-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Reports New and Updated XPOVIO® (Selinexor) Data in Relapsed or Refractory Multiple Myeloma at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
Although these data are early, six of seven patients whose disease relapsed after CAR-T achieved a response when treated with selinexor and dexamethasone alone or in combination with either Velcade® (bortezomib) or Kyprolis® (carfilzomib). |
| 2019-11-06 | Karyopharm Therapeutics Inc | Results Karyopharm Announces XPOVIO® (Selinexor) Clinical Data to be Presented at the American Society of Hematology 2019 Annual Meeting karyopharm.com ↗
In both arms the response rates and safety profile remain highly encouraging. |
| 2019-09-13 | Karyopharm Therapeutics Inc | Results Karyopharm Announces XPOVIO™ (Selinexor) Presentations at the 17th International Myeloma Workshop karyopharm.com ↗
The median OS on selinexor-dexamethasone was 11.1 months and on MAMMOTH was 9.2 months. |
| 2019-08-21 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Publication of XPOVIO™ (Selinexor) Phase 2b STORM Study Results in The New England Journal of Medicine karyopharm.com ↗
The data from the STORM study demonstrate that oral selinexor, a first-in-class XPO1 inhibitor, combined with dexamethasone twice weekly, resulted in a response rate of 26% in heavily pretreated patients. |
| 2019-07-03 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces FDA Approval of XPOVIO™ (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma karyopharm.com ↗
This indication is approved under accelerated approval based on response rate. |
| 2019-07-03 | Antengene Corporation | Regulatory Karyopharm Announces FDA Approval of XPOVIO™ (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma antengene.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIOTM (selinexor, Antengene Corporation product code ATG-010), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. |
| 2019-06-19 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Updated Data from the Phase 2b SADAL Study at the 2019 International Conference on Malignant Lymphoma karyopharm.com ↗
For the SADAL study’s primary endpoint, single-agent selinexor achieved an overall response rate (ORR) of 28.3%. |
| 2019-06-14 | Karyopharm Therapeutics Inc | Results Karyopharm Reports New and Updated Selinexor Combination Data from the Phase 1b/2 STOMP Study at the European Hematology Association 2019 Annual Meeting karyopharm.com ↗
Additionally, the Darzalex and Pomalyst arms of the STOMP study continue to demonstrate impressive response rates, including encouraging rates of very good partial responses (VGPR), which indicate a 90% or greater reduction in a patient’s disease burden. |
| 2019-03-14 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration ( FDA ) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. |
| 2019-02-28 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update karyopharm.com ↗
FDA Advisory Committee Recommends that the FDA Should Wait for Results from the Ongoing Phase 3 BOSTON Study Before Making an Approval Decision. |
| 2019-02-26 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces Outcome of FDA Advisory Committee Meeting Reviewing Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma karyopharm.com ↗
The ODAC voted 8 to 5 recommending that the FDA wait for the results from Karyopharm’s randomized, open-label, Phase 3 BOSTON study evaluating selinexor in patients with relapsed or refractory multiple myeloma, before making a final decision regarding approval. |
| 2019-01-28 | Antengene Corporation | Regulatory ATG-010, China’s first Selective Inhibitor of Nuclear Export obtains IND approval for the treatment of multiple myeloma antengene.com ↗
Antengene announced recently that ATG-010, a new Category I drug developed by the company to treat patients with relapsed and/or refractory multiple myeloma, received the IND approval from the National Medical Products Administration on January 28, 2019. |
| 2019-01-08 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma karyopharm.com ↗ |
| 2018-10-05 | Karyopharm Therapeutics Inc | Regulatory U.S. Food and Drug Administration Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review karyopharm.com ↗
The FDA also granted Karyopharm’s request for Priority Review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA). |
| 2018-09-22 | Antengene Corporation | Results Antengene publishes clinical data on ATG-010 (Selinexor) for the treatment of refractory and/or relapsed multiple myeloma and relapsed diffuse large B-cell lymphoma at the Annual Meeting of Chinese Society of Clinical Oncology antengene.com ↗
We have reported positive clinical data of the phase 2b STORM clinical trial today |
| 2018-08-07 | Antengene Corporation | Regulatory Karyopharm，Antengene Corporation’s Strategic Partner, Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor （ATG-010）as a Treatment for Patients with Penta-Refractory Multiple Myeloma antengene.com ↗
The completion of our first NDA submission marks a significant achievement for Karyopharm and brings oral selinexor one step closer to these patients. |
| 2018-08-06 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for selinexor, its novel, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma. |
| 2018-07-18 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma karyopharm.com ↗ |
| 2018-07-18 | Antengene Corporation | Regulatory Antengene Corporation’s Strategic Partner, Karyopharm Therapeutics, Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma antengene.com ↗ |
| 2018-04-30 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Positive Top-Line Data from Phase 2b STORM Study Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma karyopharm.com ↗
Regarding the STORM study’s primary objective, oral selinexor achieved a 25.4% overall response rate (ORR), which included two complete responses (CRs) and 29 partial (PRs) or very good partial responses (VGPRs) in these patients with penta-refractory myeloma. |
| 2018-04-10 | Karyopharm Therapeutics Inc | Regulatory Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. |
| 2018-03-19 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Preclinical Data at the American Association for Cancer Research 2018 Annual Meeting karyopharm.com ↗
Galinski et al. show that the combination of selinexor with bortezomib (SV) is synergistic and reduces the activity of nuclear factor kappa-B (NFkB) in aggressive neuroblastoma cell lines. |
| 2017-09-20 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Successful Outcome from Phase 2 Portion of Phase 2/3 SEAL Study Evaluating Selinexor in Patients with Previously Treated Advanced Dedifferentiated Liposarcoma karyopharm.com ↗
For the SEAL study's primary endpoint of progression-free survival (PFS), oral selinexor showed superiority over placebo, achieving a hazard ratio (HR) of 0.60, representing a 40% reduction in the risk of progression or death. |
| 2017-09-08 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Presentation of Selinexor and KPT-9274 Clinical Data at the European Society of Medical Oncology 2017 Annual Meeting karyopharm.com ↗ |
| 2017-04-04 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Interim Phase 2b SADAL Data at the 2017 American Association for Cancer Research Annual Meeting karyopharm.com ↗
In the SADAL study, selinexor achieved a 28.6% overall response rate (ORR) in patients with relapsed or refractory DLBCL. |
| 2017-03-30 | Karyopharm Therapeutics Inc | Regulatory U.S. FDA Division of Hematology Products Lifts Partial Clinical Hold on Karyopharm's Selinexor Clinical Trials karyopharm.com ↗
Enrollment may now resume in all selinexor studies in hematologic malignancies, including the STORM study in refractory multiple myeloma, the SADAL study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL), and the STOMP study of selinexor and backbone therapies in multiple myeloma. |
| 2017-03-10 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces Partial Clinical Hold to Pause Enrollment in Selinexor Trials karyopharm.com ↗ |
| 2017-03-02 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Results from Interim Analysis of Phase 2 SOPRA Study Evaluating Selinexor in Relapsed/Refractory Acute Myeloid Leukemia karyopharm.com ↗
The Company determined in concert with the study's independent Data Safety Monitoring Board (DSMB) that SOPRA will not reach statistical significance for overall survival (OS), the study's primary endpoint. |
| 2016-12-05 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Updated Phase 1b STOMP Data at the American Society of Hematology 2016 Annual Meeting karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced updated results from the Phase 1b dose-escalation portion of its ongoing STOMP study showing high response rates when selinexor (KPT-330) is combined with the proteasome inhibitor bortezomib (Velcade®), including in patients with multiple myeloma (MM) that was previously refractory to proteasome inhibitors, at the American Society of Hematology (ASH) 2016 annual meeting held December 3-6, 2016 in San Diego. |
| 2016-12-04 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Updated Phase 2b STORM Data at the American Society of Hematology 2016 Annual Meeting karyopharm.com ↗ |
| 2016-12-04 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Updated Phase 2 SAIL Relapsed/Refractory AML Clinical Data at the American Society of Hematology 2016 Annual Meeting karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced updated results from the Phase 2 SAIL study, in which deep responses to selinexor (KPT-330) allowed patients with heavily pretreated acute myeloid leukemia (AML) to proceed onto stem cell transplantation or donor lymphocyte transfusion, at the American Society of Hematology (ASH) 2016 annual meeting held December 3-6, 2016 in San Diego. |
| 2016-11-07 | Karyopharm Therapeutics Inc | Results Karyopharm Reports Third Quarter 2016 Financial Results and Highlights Recent Progress karyopharm.com ↗
The ORRs were 21% in patients with quad-refractory disease and 20% in patients with penta-refractory disease, all based on Independent Review Committee (IRC) adjudication. |
| 2016-11-03 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Updated Phase 2b STORM and Phase 1b STOMP Clinical Data at the American Society of Hematology 2016 Annual Meeting karyopharm.com ↗ |
| 2016-10-05 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Updated SIGN Phase 2 Clinical Data at European Society of Medical Oncology 2016 Annual Meeting karyopharm.com ↗
In the oral presentation, titled " Results of a Phase 2 Trial of Selinexor, an Oral Selective Inhibitor of Nuclear Export (SINE) in 114 Patients with Gynecological Cancers ," Ignace B. Vergote, MD, PhD, Head of the Department of Gynecologic Oncology, Catholic University of Leuven, Belgium, and lead investigator of the SIGN study, will describe clinical data from the study, which includes durable anti-cancer activity in gynecological malignancies with disease control rates up to 49% and good tolerability. |
| 2016-09-29 | Karyopharm Therapeutics Inc | Results Karyopharm Publishes Preclinical Data in Nature Demonstrating Selinexor's Potential in KRAS-Mutant Non-Small Cell Lung Cancer (NSCLC) karyopharm.com ↗
In the manuscript, scientists from the University of Texas Southwestern Medical Center and Karyopharm demonstrated that KRAS-mutant NSCLC cells are addicted to Exportin 1 (XPO1) and that inhibition with selinexor induced robust cellular apoptosis of these malignant cells, both in vitro and in vivo. |
| 2016-09-28 | Karyopharm Therapeutics Inc | Results Karyopharm Publishes Preclinical and Phase 1 Clinical Data for Selinexor in Ovarian Cancer in Clinical Cancer Research Publication karyopharm.com ↗
In this study, selinexor had manageable toxicity and tumor growth was halted in three of five evaluable patients, including one patient with a confirmed partial response. |
| 2016-07-27 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Phase 1b Selinexor Sarcoma Data Published in Journal of Clinical Oncology karyopharm.com ↗
Of the 52 evaluable patients, 30 (58%) showed a best response of stable disease (SD), with 17 (33%) experiencing durable SD (≥4 months). |
| 2016-06-10 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Preliminary STOMP Phase 1b Clinical Data at 2016 European Hematology Association Annual Meeting karyopharm.com ↗
We are highly encouraged by the promising, durable activity and safety we continue to observe in the STOMP trial, |
| 2016-05-19 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Preliminary STOMP Phase 1B Clinical Data at 2016 European Hematology Association Annual Meeting karyopharm.com ↗
These clinical data further support the synergistic activity of selinexor in combination with proteasome inhibitors and immunomodulatory agents, or iMiDs, which was previously demonstrated in preclinical models of multiple myeloma. |
| 2016-05-18 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Selinexor Clinical Data at the American Society of Clinical Oncology Annual Meeting karyopharm.com ↗
We are also excited about the response rates observed to date with selinexor in combination with doxorubicin and dexamethasone in relapsed and refractory multiple myeloma. |
| 2016-03-04 | Karyopharm Therapeutics Inc | Results Karyopharm's Selinexor First-in-Human Phase 1 Clinical Trial Data Published in Journal of Clinical Oncology karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, announced today the publication of results from a Phase 1 clinical trial of selinexor in patients with advanced solid tumors in the Journal of Clinical Oncology. |
| 2015-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Presents Positive Clinical Data on the Activity of Selinexor in Combination with Other Anticancer Agents across Multiple Hematologic Malignancies at the 2015 American Society of Hematology (ASH) Annual Meeting karyopharm.com ↗
Data presented at ASH demonstrate that selinexor is efficacious and often synergistic in combination with other therapeutic agents |
| 2015-06-01 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Clinical Data for Selinexor (KPT-330) in Patients With Recurrent Glioblastoma and Advanced Sarcomas at 2015 ASCO Annual Meeting karyopharm.com ↗
In an ongoing Phase 2 clinical trial, single-agent oral selinexor demonstrated anti-tumor activity in patients with recurrent glioblastoma, including brain penetration at clinically relevant drug levels, with a 13% overall response rate and a 38% disease control rate. |
| 2015-05-30 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Clinical Data for Selinexor (KPT-330) in Patients With Heavily Pretreated Gynecological Cancers and Asian Patients With Advanced Malignancies at 2015 ASCO Annual Meeting karyopharm.com ↗
In a Phase 1 clinical trial evaluating the activity of selinexor in Asian patients with advanced malignancies, single-agent selinexor demonstrated anti-tumor activity across a variety of malignancies in this patient population. |
| 2015-05-21 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Hematologic Cancer Data on Lead Drug Candidate Selinexor at European Hematology Association Annual Meeting karyopharm.com ↗
An overall response rate of 53% (eight) was achieved based on fifteen evaluable patients and 67% (six) of those patients went on to receive either stem cell transplant or donor lymphocyte infusion. |
| 2015-05-13 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Solid Tumor Data on Lead Drug Candidate Selinexor at 2015 American Society of Clinical Oncology Annual Meeting karyopharm.com ↗
We are also particularly excited about the clear demonstration of brain penetration and anti-tumor activity of single-agent selinexor in relapsed or refractory glioblastomas. |
| 2015-04-17 | Karyopharm Therapeutics Inc | Results Karyopharm to Present Late-Breaking Data at American Association for Cancer Research Annual Meeting karyopharm.com ↗
The combination of selinexor and olaparib was shown to act synergistically to induce apoptosis and amplify anti-tumor effects in mouse model of BRCA1 mutant breast cancer. |
| 2015-01-08 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces Orphan Designation Granted by FDA for Selinexor (KPT-330) in Multiple Myeloma karyopharm.com ↗
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that its lead drug candidate, selinexor (KPT-330), has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. |
| 2014-12-08 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Positive Combination Data for Selinexor (KPT-330) in Multiple Myeloma Patients at ASH 2014 Annual Meeting karyopharm.com ↗
Six of these patients remained on study for at least 16 weeks, including two for 28 and 43 weeks, respectively, who remained on study as of December 1, 2014. |
| 2014-12-08 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Positive Clinical Data for Selinexor (KPT-330) in NHL Patients at ASH 2014 Annual Meeting karyopharm.com ↗
Responses included five complete responses, four in patients with DLBCL and one in a patient with T-cell lymphoma, and Selinexor demonstrated a median duration of response (DOR) of approximately 7 months. |
| 2014-12-01 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces Additional Orphan Designations Granted for Selinexor (KPT-330) by European Commission karyopharm.com ↗
Selinexor (KPT-330), has received orphan drug designation from the European Medicines Agency (EMA) of the European Commission |
| 2014-11-24 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Data on Oncology Pipeline at EORTC-NCI-AACR Annual Meeting karyopharm.com ↗
These results suggest that such a combination treatment has the potential to result in improved clinical outcomes compared to each agent alone: Selinexor treatment following exposure to DNA damaging agents such as doxorubicin and idarubicin inhibited the repair mechanism of DNA damage caused by these agents and resulted in synergistic Acute Myeloid Leukemia (AML) cell killing as measured by induction of PARP and Caspase 3 cleavage. |
| 2014-11-06 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Data Presentations at American Society of Hematology Annual Meeting karyopharm.com ↗
The Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Demonstrates Broad and Durable Clinical Activity in Relapsed / Refractory Non-Hodgkin's Lymphoma (NHL) |
| 2014-09-29 | Karyopharm Therapeutics Inc | Results Karyopharm Announces Clinical Data for Selinexor (KPT-330) in Advanced Solid Tumors karyopharm.com ↗
Selinexor also demonstrated early signs of clinical activity in other solid tumor indications including head and neck squamous cell carcinoma and ovarian cancer. |
| 2014-08-07 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Therapeutics Reports Second Quarter Financial Results for 2014 karyopharm.com ↗
Today, Karyopharm announced it has also received orphan drug designation for AML and DLBCL from the European Medicines Agency (EMA). |
| 2014-06-13 | Karyopharm Therapeutics Inc | Results Karyopharm Announces First Combination Data of Selinexor With Low-Dose Dexamethasone in Heavily Pretreated Multiple Myeloma Patients karyopharm.com ↗
Among eight patients, the best responses were one stringent complete response (sCR), three partial responses (PRs), two minor responses (MRs), one progressive disease and one non-evaluable. |
| 2014-06-02 | Karyopharm Therapeutics Inc | Results Karyopharm Updates Data for Selinexor in Solid Tumors at 2014 ASCO Annual Meeting karyopharm.com ↗
Partial responses were observed in 4 patients: colorectal cancer (KRAS mutant), melanoma (BRAFwt), ovarian adenocarcinoma, and cervical. |
| 2014-05-31 | Karyopharm Therapeutics Inc | Results Karyopharm Provides Data Update for Selinexor in Non-Hodgkin's Lymphoma and Acute Myeloid Leukemia at 2014 ASCO Annual Meeting karyopharm.com ↗
The data indicate that first-in-class oral Selinexor showed continued evidence of anti-cancer activity as a single agent in patients with heavily pretreated Non-Hodgkin's Lymphoma (NHL) and Acute Myeloid Leukemia (AML) who had progressive disease on study entry. |
| 2014-05-20 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Announces Second Orphan Drug Designation for Selinexor in Diffuse Large B-Cell Lymphoma (DLBCL) karyopharm.com ↗
today announced that its lead drug candidate, Selinexor (KPT-330), has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). |
| 2014-05-19 | Karyopharm Therapeutics Inc | Regulatory Karyopharm Receives Orphan Drug Designation for Acute Myeloid Leukemia (AML) karyopharm.com ↗ |
| 2014-01-22 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Presents Clinical Data on Selinexor (KPT-330) in Colorectal Cancer From Ongoing Phase 1 Study and Preclinical Data on Novel PAK4 Inhibitors at American Society of Clinical Oncology 2014 Gastrointestinal Cancers Symposium karyopharm.com ↗
The data presented included an update (as of December 16, 2013) from the ongoing Phase 1 study of oral Selinexor in solid tumors that show preliminary evidence of antitumor activity in metastatic colorectal cancer (CRC) patients. |
| 2013-12-08 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Presents Promising Data for Selinexor, an Oral, First-in-Class Selective Inhibitors of Nuclear Export (SINE) Compound, in Hematologic Malignancies at 2013 ASH Annual Meeting karyopharm.com ↗
Treatment induced partial responses in 27% of the patients across all disease types (see table), with tumor (lymph node) shrinkage observed in the majority of patients (17 of 18 patients who had baseline and at least one follow up CT scan. |
| 2013-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Announces Highlights From Poster Presentations on Selective Inhibitors of Nuclear Export (SINE) Compounds in Hematologic Malignancies at 2013 ASH Annual Meeting karyopharm.com ↗
We believe our ongoing Phase 1 dose escalation clinical study in patients with progressive, relapsed, refractory AML and MM suggest that the observed activity in preclinical models evaluating SINE compounds may translate into clinical activity. |
| 2013-08-07 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Announces Preclinical Data for Selinexor (KPT-330) in Acute Myeloblastic Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) Models at FASEB Science Research Conferences karyopharm.com ↗
The poster provided preclinical data showing evidence that Karyopharm’s proprietary SINE Exportin 1 (XPO1 or CRM1) antagonists induce apoptosis of leukemic cells in models of AML and ALL. |
| 2013-06-02 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Presents Clinical Data for Selinexor (KPT-330), a First-in-Class Selective Inhibitor of Nuclear Export (SINE), in Solid Tumors at the 2013 ASCO Annual Meeting karyopharm.com ↗
The data suggest that selinexor is generally safe and well tolerated as a single agent and exhibits the first signs of clinical efficacy in heavily pre-treated patients with advanced solid tumors even at low dose levels. |
All press releases naming this drug 253 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 253 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 190 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Selinexor | “This study aims to evaluate the efficacy and safety of the VPX regimen, a novel combination of teniposide, PD-1 monoclonal antibody and selinexor, in patients with...” NCT07074470 ↗185“For relapsed refractory MCL patients who had received BTK inhibitors: selinexor 60mg once daily on days 1 and 8, zuberitamab 375 mg/m² on day 0, Dexamethasone 20 mg on days 1-3...” NCT07264894 ↗ “the XAB regimen: a chemotherapy-free or low-dose chemotherapy regimen containing selinexor (X), azacitidine (A), and venetoclax (B)” NCT07236931 ↗ “Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles” NCT07523737 ↗ “COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)” NCT05833893 ↗ “Selinexor 40mg/d，po d1,8,15” NCT06062641 ↗ |
| Known as | ATG-010 | “Selinexor（ATG-010）” NCT04941937 ↗ |
| Known as | KPT-330 | “Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM).” NCT04925193 ↗8“Selinexor (also called KPT-330), works by trapping "tumor suppressor proteins" within the cell and thus causing the cancer cells to die or stop growing.” NCT03042819 ↗ “This schedule will be combined with oral selinexor (KPT-330) for three weeks at days and dose according to escalation level:” NCT03661515 ↗ “Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas” NCT01986348 ↗ “Selinexor (KPT-330) is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2).” NCT06225310 ↗ “A Phase 1 Study of Selinexor (KPT-330), A Selective XPO1 Inhibitor” NCT02323880 ↗ “Selective Inhibitor Of Nuclear Export (SINE) Selinexor (KPT-330)” NCT02249091 ↗ “Drug: selinexor (KPT-330)” NCT02228525 ↗ “Selinexor (KPT-330)” NCT02831686 ↗ |
| Known as | SEL | “Preclinical studies showed a synergistic antileukemia activity with combination of selective XPO1 inhibitor selinexor (SEL) and venetoclax (VEN), with potential to overcome VEN...” PMID 41796974 ↗ Mar 20261“BACKGROUND: Selinexor (SEL) is an oral inhibitor of nuclear export protein Exportin 1 (XPO1) previously shown to upregulate programmed cell death protein 1 (PD-L1) and...” PMID 40502306 ↗ Jun 2025 |
| Known as | Xpovio | “Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM).” NCT04925193 ↗1“Selinexor Oral Tablet [Xpovio]” NCT06517511 ↗ |
| Action | Inhibit | “Selinexor is the first oral selective inhibitor of nuclear export compound tested for cancer treatment.” PMID 28630120 ↗ Jun 2017 |
| Modality | Other / unclassified | “SINE™ compound selinexor” NCT02314247 ↗ |
| Route | Oral | “Participants with colorectal cancer and liver metastasis received oral selinexor as single agent” NCT01607905 ↗ |
| Target | XPO1 | “clinical exportin 1 (XPO1) inhibitor selinexor (KPT-330)” PMID 27557643 ↗ Aug 2016 |