- The US Food and Drug Administration (FDA) has approved selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM).
- Selinexor is indicated for patients who have received ≥4 prior therapies and whose disease is resistant to several other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 antibody.
Why this matters
- Many patients eventually develop resistance to the most commonly used antimyeloma drugs currently available.
- This is the first FDA approval in the selective inhibitor of nuclear export (SINE) class.
- Phase 2b STORM study to investigate selinexor+dexamethasone in 83 patients refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab.
- 65 (range, 40-86) years median patient age.
- 81% had undergone prior stem cell transplantation.
- 57% had high-risk cytogenetics.
- Funding: Karyopharm Therapeutics Inc.
- 25.3% (95% CI, 16.4%-36%) overall response rate (ORR).
- 4 (range, 1-10) weeks median time to first response.
- 3.8 months (95% CI, 2.3-not estimable) median duration of response.
- Common hematologic adverse events (AEs) with selinexor+dexamethasone included leukopenia, neutropenia, thrombocytopenia, and anemia.
- Other AEs included vomiting, nausea, fatigue, and hyponatremia.
- Accelerated approval; continued approval may be contingent upon confirmatory trial results.
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