Xpovio® is the official global commercial brand name, and Xiweiao is its Chinese brand name developed by Karyopharm and exclusively commercialized by Dizal Pharma. It is an oral selective inhibitor of nuclear export (SINE). It selectively blocks exportin 1 (XPO1), retains tumor suppressor proteins inside the cell nucleus, restores their anti-tumor function and induces apoptosis of malignant hematologic tumor cells.
Main Indications
Combined with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen;
Combined with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy;
Monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma after at least two lines of systemic therapy.
Clinical Research
Global multicenter phase III BOSTON pivotal trial fully validated significant progression-free survival benefit of selinexor, bortezomib and dexamethasone regimen versus standard bortezomib plus dexamethasone for previously treated multiple myeloma;
Global phase IIb STORM trial confirmed durable objective response rate in heavily pretreated multi-line refractory myeloma patients receiving selinexor combined with dexamethasone;
Phase II SADAL registration trial demonstrated sustained anti-tumor activity in relapsed/refractory diffuse large B-cell lymphoma for patients with limited treatment options;
Dose-finding research verified balanced anti-tumor efficacy and gastrointestinal and hematologic safety profile of the 20mg oral standard dose;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic patients with relapsed/refractory hematological malignancies.
Common Side Effects
Common mild adverse reactions: Nausea, vomiting, diarrhea, decreased appetite, fatigue, thrombocytopenia and hyponatremia;
Laboratory abnormalities: Transient leukopenia, neutropenia and elevated liver enzymes;
Severe but uncommon risks: Severe persistent gastrointestinal toxicity, grade 3–4 thrombocytopenia, severe hyponatremia, infectious complications and neurological adverse events.
Approval Status in China
Original drug Xpovio® was officially approved for marketing in China in 2021, with the specification of 20mg per tablet, 16 tablets per box. It is currently a prescription oral anti-tumor drug for hematological malignancies included in China’s Category B medical insurance catalogue.
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