FDA Grants Accelerated Approval to Selinexor Combination for Resistant Myeloma
Posted: Monday, July 8, 2019
On July 3, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Efficacy was evaluated in 83 patients (ClinicalTrials.gov identifier NCT02336815) with relapsed or refractory multiple myeloma who were treated with selinexor in combination with dexamethasone in the phase IIb STORM trial. At the end of the study, the overall response rate was 25.3%. The median time to first response was 4 weeks, with a range of 1 to 10 weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.
Common side effects reported in patients treated with selinexor in combination with dexamethasone include leukopenia, neutropenia, thrombocytopenia, and anemia. Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections, and hyponatremia.
