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.