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FDA Approval

FDA Approves Selinexor in Combination With Bortezomib and Dexamethasone for MM

December 18, 2020

On December 18, 2020, the FDA granted approval to selinexor (Xpovio, Karyopharm Therapeutics) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who received ≥1 prior therapy.

This approval is based on efficacy results from the BOSTON trial, which randomized patients 1:1 to receive selinexor in combination bortezomib and low-dose dexamethasone (SVd) or standard bortezomib plus low-dose dexamethasone (Vd).

The main efficacy outcome measure was progression-free survival (PFS).

Median PFS was estimated at 13.9 months (95% CI: 11.7, Not Estimable) for the SVd arm compared to 9.5 months (95% CI: 7.6, 10.8) for the Vd arm (estimated hazard ratio 0.70; 95% CI: 0.53, 0.93).

Common adverse events associated with the therapy, occurring in ≥20% of patients, include nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection decreased weight, cataract and vomiting.—Janelle Bradley

Source: US Food and Drug Administration. FDA approves selinexor for refractory or relapsed multiple myeloma. December 18, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-selinexor-refractory-or-relapsed-multiple-myeloma. Accessed December 18, 2020.

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