Karyopharm Therapeutics Inc. submitted a new drug application with the U.S. Food and Drug Administration seeking accelerated approval for Xpovio, or selinexor, to treat patients with diffuse large B-cell lymphoma, or DLBCL.
DLBCL is a cancer that starts in infection-fighting cells called lymphocytes and shows itself through pea-sized glands in parts of the body that are part of the immune system.
The Newton, Mass.-based company is seeking approval for its oral treatment in patients who are ineligible for stem cell transplants and whose DLBCL recurs or persists even after two other therapies. The treatment has received both the orphan drug and fast track designations from the FDA in this indication.
Selinexor targets cancer cells by depriving them of exportin 1, a protein used by parts of a cell to interact with each other.
In July, selinexor received accelerated approval from the FDA to treat multiple myeloma, an incurable blood cancer that forms in a type of white blood cells. In September, Karyopharm sold tiered royalty rights for selinexor to HealthCare Royalty Partners for $75 million.