3 July 2019 - Today, the U.S. FDA granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed 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 with relapsed/refractory multiple myeloma who were treated with Xpovio in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%.

The FDA granted this application Fast Track designation. Xpovio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. 

The FDA granted the approval of Xpovio to Karyopharm Therapeutics.

Read FDA press release