Karyopharm Therapeutics Inc. has applied to market its medicine Selinexor, which treats a highly resistant form of blood cancer, with the European Medicines Agency.
The Newton, Mass.-based company is seeking approval for Selinexor in patients with refractory multiple myeloma whose disease has not responded to three prior treatments. Multiple myeloma occurs when plasma cells, found in the bone marrow, become cancerous and grow out of control.
The application is based on positive results from a phase 2 trial named Storm, which found that Selinexor shrank tumors in patients with the aggressive blood cancer.
Karyopharm Therapeutics said the European Medicines Agency's Committee for Medicinal Products for Human Use has granted accelerated assessment to Selinexor, which could reduce review time of the marketing authorization application to 150 days from the standard 210 days.
The U.S. Food and Drug Administration has granted a priority review to Selinexor for the same type of cancer and has set a decision date of April 6.