Antengene Receives Approval In China For XPOVIO For Treatment Of Refractory Multiple Myeloma

(RTTNews) - Karyopharm Therapeutics Inc. (KPTI) said that its partner, Antengene, has been granted conditional approval for marketing by the China National Medical Products Administration for XPOVIO (selinexor), a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have received prior therapies and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Antengene has exclusive development and commercialization rights to selinexor in China and certain Asia Pacific countries.

The conditional approval was based on the global Phase 2 STORM trial as well as results from Antengene's Phase 2 MARCH trial in China, which evaluated the efficacy and safety of selinexor plus dexamethasone in patients with relapsed/refractory multiple myeloma.

Karyopharm noted that the ongoing, randomized Phase 3 BENCH trial evaluating selinexor in combination with bortezomib and low-dose dexamethasone will serve as the confirmatory trial.