The FDA granted accelerated approval to Karyopharm Therapeutics’ Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adults with relapsed refractory multiple myeloma.
The approval is for patients 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.
The agency based the accelerated approval on a trial involving 83 patients, with an overall response rate of 25.3 percent. The median time to first response was four weeks. The efficacy study was supported by data from an ongoing trial in patients with multiple myeloma.