US approval has been granted to Karyopharm Therapeutics’ Xpovio in combination with dexamethasone for treating adult patients with relapsed or refractory multiple myeloma (RRMM).
The decision from the FDA means that Xpovio (selinexor) is currently the first and only nuclear export inhibitor approved in the US.
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, randomised Phase 3 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 said it expects Xpovio to become commercially available in the US on or before July 10, 2019.
A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency.