The FDA approved Karyopharm Therapeutics (NASDAQ:KPTI) XPOVIO, in combination with dexamethasone, for the treatment of relapsed or refractory multiple myeloma (RRMM).
XPOVIO, previously referred to as selinexor, is a nuclear export compound that causes the accumulation of tumor suppressor proteins in the cell nucleus, inducing apoptosis in cancer cells.
XPOVIO’s RRMM indication is approved under the FDA’s accelerated approval program based on the drug’s response rate. Karyopharm notes that continued approval for this indication may depend on a confirmatory trial’s demonstration of clinical benefit.
“The 25.3% response rate seen in the subgroup of 83 patients in the pivotal Phase 2b STORM study that served as the basis for XPOVIO’s accelerated approval is clinically meaningful and a validated surrogate marker for clinical benefit in our patients with advanced refractory disease,” Dr. Sundar Jagannath, principal investigator of the STORM study, said in a statement.
Karyopharm is currently conducting a Phase 3 study of XPOVIO in RRMM patients, with data expected by the end of 2019 or early 2020. The trial will determine if XPOVIO can delay tumor progression and improve overall survival compared to current standard of care.
Karyopharm expects to launch XPOVIO in the U.S. by July 10, 2019.
