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DrugXpovio™ (selinexor) [Karyopharm Therapeutics, Inc.]

December 2019

Therapeutic Area - Oncology Agents, Oral – Hematologic Cancers

Approval criteria

  • Patient is ≥ 18 years of age; AND
  • Patient has diagnosis of relapsed or refractory multiple myeloma; AND
  • Patient does not have smoldering myeloma, central nervous system myeloma, systemic amyloid light chain amyloidosis or plasma cell leukemia; AND
  • Patient has tried and failed (≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy) each of the following regimens:
    • At least 2 proteasome inhibitors (e.g., bortezomib, ixazomib, or carfilzomib); AND
    • At least 2 immunomodulatory agents (e.g., thalidomide, lenalidomide, pomalidomide, thalidomide); AND
    • An anti-CD38 monoclonal antibody (e.g., daratumumab).
  • Initial approval is for 6 months

Renewal Criteria

  • Patient continues to meet the above criteria; AND
  • Documentation of effectiveness, as defined by tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug (e.g., thrombocytopenia, neutropenia, gastrointestinal toxicity [nausea, vomiting, diarrhea, anorexia, weight loss], hyponatremia, infections, neurological toxicity [dizziness, confusion]).
  • Renewal approval is for 6 months

Quantity limits

  • 32 tablets/28 days


Xpovio is FDA-pproved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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