Xpovio™
Drug - Xpovio™ (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
Background
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.
Questions?
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