FDA Approves Karyopharm's Xpovio To Treat Multiple Myeloma After At Least One Prior Therapy

(RTTNews) - Antengene Corporation Limited said that its U.S. Partner, Karyopharm Therapeutics Inc. (KPTI), received an approval from the U.S. Food and Drug Administration for oral Xpovio drug, in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The indication was approved three months ahead of its March Prescription Drug User Fee Act (PDUFA) date based on the result of a confirmatory Phase 3 BOSTON study. The study evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy.

Xpovio or Selinexor was previously approved under the FDA's Accelerated Approval Program for the treatment of adult patients with relapsed or refractory multiple myeloma 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.

Xpovio is, now the only drug approved by FDA for use in both multiple myeloma and diffuse large B-cell lymphoma, discovered and developed by Karyopharm.

Xpovio is currently being developed by Antengene, who has the exclusive development and commercial rights in certain Asia-Pacific markets, including China.