{"entity":{"id":"selinexor","kind":"drug","name":"Selinexor","aka":[],"tldr":"Selinexor is a first-in-class pill that traps tumour-suppressor proteins inside the nucleus; approved in myeloma, it failed its endometrial cancer test in 2026.","summary":"Approved 2019 (penta-refractory myeloma with dexamethasone), 2020 (DLBCL; with bortezomib in myeloma, BOSTON). In endometrial cancer, SIENDO (2022) missed its primary endpoint but a TP53-wild-type subgroup showed a large PFS difference; the confirmatory XPORT-EC-042 missed its primary endpoint in July 2026. Nausea, fatigue, weight loss, and thrombocytopenia limit tolerability.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Selinexor","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Selinexor"}],"tags":[],"related":[],"cancers":["endometrial","multiple-myeloma","dlbcl","myeloma-relapsed-refractory"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["tp53"],"drugs":[],"companies":["karyopharm","antengene"],"institutions":[],"pathways":[],"terms":[],"trials":["xport-ec-042","nct04442022","nct06158841","nct02227251","nct02343042","nct04414475","nct04782687","nct04562389"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Xpovio","code":"KPT-330","modality":"Small-molecule XPO1 (nuclear export) inhibitor","mechanism":"Covalent inhibitor of exportin-1 (XPO1/CRM1), retaining p53, RB, FOXO, and other tumour suppressors in the nucleus and reducing oncoprotein translation.","approvals":[{"region":"US","year":2019,"indication":"Relapsed/refractory multiple myeloma (≥4 lines) with dexamethasone"},{"region":"US","year":2020,"indication":"Relapsed/refractory DLBCL; myeloma with bortezomib after ≥1 line"},{"region":"EU","year":2021,"indication":"EU brand Nexpovio","note":"Conditional marketing authorisation"}],"mechanismSteps":["Binds XPO1 in the nuclear pore complex","Tumour suppressors (p53, p21, RB) accumulate in the nucleus","Oncogene mRNAs (MYC, cyclin D) are not exported","Cells with intact p53 arrest or die"],"dosing":{"route":"Oral","schedule":"80 mg weekly with dexamethasone (myeloma); 60 mg weekly (endometrial trials)","monitoring":"Weekly CBC, sodium, weight; antiemetic prophylaxis"},"toxicity":[{"event":"Nausea","anyGradePct":84,"grade3PlusPct":10,"note":"SIENDO selinexor arm"},{"event":"Thrombocytopenia","anyGradePct":43,"grade3PlusPct":9},{"event":"Fatigue","anyGradePct":49,"grade3PlusPct":9}],"access":[],"regulatoryEvents":[{"date":"2019-07-03","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody"},{"date":"2020-06-22","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://wayback.archive-it.org/7993/20201222062817/https:/www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-relapsedrefractory-diffuse-large-b-cell-lymphoma","indication":"Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (FL), after at least 2 lines of systemic therapy."},{"date":"2020-12-18","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2019 converted to traditional approval 1.5 years after it was granted.","indication":"In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody"},{"date":"2026-04-30","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 5.9 years after its accelerated approval.","source":"https://wayback.archive-it.org/7993/20201222062817/https:/www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-relapsedrefractory-diffuse-large-b-cell-lymphoma","indication":"Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (FL), after at least 2 lines of systemic therapy."},{"date":"2026-07-30","type":"filing","region":"US","note":"XPORT-EC-042 misses primary endpoint; endometrial development deprioritised","source":"https://cancerletter.com/clinical-roundup/20260807_8a/"}]},"route":"/drugs/selinexor/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"endometrial-nsmp","kind":"cancer","name":"Endometrial cancer with no specific molecular profile","route":"/cancers/endometrial-nsmp/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"plasma-cell-leukaemia","kind":"cancer","name":"Plasma cell leukaemia","route":"/cancers/plasma-cell-leukaemia/"},{"id":"primary-myelofibrosis","kind":"cancer","name":"Primary myelofibrosis","route":"/cancers/primary-myelofibrosis/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"xpo1","kind":"target","name":"Exportin-1 (XPO1)","route":"/targets/xpo1/"},{"id":"tp53","kind":"target","name":"TP53","route":"/targets/tp53/"}],"company":[{"id":"antengene","kind":"company","name":"Antengene","route":"/companies/antengene/"},{"id":"karyopharm","kind":"company","name":"Karyopharm Therapeutics","route":"/companies/karyopharm/"}],"trial":[{"id":"nct04442022","kind":"trial","name":"A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Ly","route":"/trials/nct04442022/"},{"id":"nct04414475","kind":"trial","name":"A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refrac","route":"/trials/nct04414475/"},{"id":"nct02227251","kind":"trial","name":"Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","route":"/trials/nct02227251/"},{"id":"nct05035745","kind":"trial","name":"Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)","route":"/trials/nct05035745/"},{"id":"nct02343042","kind":"trial","name":"Selinexor and Backbone Treatments of Multiple Myeloma Patients","route":"/trials/nct02343042/"},{"id":"nct06158841","kind":"trial","name":"Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refracto","route":"/trials/nct06158841/"},{"id":"nct04562389","kind":"trial","name":"Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis","route":"/trials/nct04562389/"},{"id":"nct04782687","kind":"trial","name":"Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma","route":"/trials/nct04782687/"},{"id":"nct06813079","kind":"trial","name":"Using Tumor Models to Determine Treatments","route":"/trials/nct06813079/"},{"id":"xport-ec-042","kind":"trial","name":"XPORT-EC-042 / ENGOT-EN20 / GOG-3083","route":"/trials/xport-ec-042/"}]}}