FDA approves Xpovio to treat multiple myeloma

Karyopharm Therapeutics Inc. announced that the FDA has approved oral Xpovio (selinexor), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The ongoing, randomized Phase III BOSTON study evaluating selinexor in combination with Velcade (bortezomib) and low-dose dexamethasone will serve as the confirmatory trial.

The FDA’s Accelerated Approval Program was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need.

Karyopharm expects Xpovio to become commercially available in the U.S. on or before July 10, 2019. A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency.