In December 2020, the FDA approved Xpovio (selinexor; from Karyopharm Therapeutics), an XPO1 inhibitor, for use in combination with the proteasome inhibitor Velcade (bortezomib) and the steroid dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous therapy.
Xpovio was previously approved, in combination with dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma who have received 4 or more previous therapies, and for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after 2 or more lines of systemic therapy.
The FDA approved this new indication based on the results of a randomized clinical trial of patients with relapsed or refractory multiple myeloma who had received between 1 and 3 previous therapies. Patients were divided to receive Xpovio plus Velcade and low-dose dexamethasone or standard therapy with only Velcade and low-dose dexamethasone.
The average time without disease progression was 13.9 months in patients who received Xpovio plus Velcade and low-dose dexamethasone compared with 9.5 months in patients who received only Velcade and low-dose dexamethasone, demonstrating the benefit of adding Xpovio to the treatment regimen.
The most common side effects with the 3-drug combination were nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract, and vomiting.