Posted by Michael Wonder on 06 Aug 2018
Karyopharm completes rolling submission of new drug application to U.S. FDA for selinexor as a treatment for patients with penta-refractory multiple myeloma
6 August 2018 - Selinexor has received both orphan drug and fast track designations from the FDA for this indication.
Karyopharm Therapeutics today announced the completion of the rolling submission of a new drug application to the U.S. FDA seeking accelerated approval for selinexor, its novel, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have previously received the two proteasome inhibitors (PIs), Velcade (bortezomib) and Kyprolis (carfilzomib), the two immunomodulatory drugs (IMiDs), Revlimid (lenalidomide) and Pomalyst (pomalidomide), and the anti-CD38 monoclonal antibody Darzalex (daratumumab) as well as alkylating agents, and their disease is refractory to at least one PI, at least one IMiD, Darzalex and their most recent therapy.
Pending marketing approval by the FDA, Karyopharm plans to commercialize selinexor in the U.S. Should the application be approved by the FDA, selinexor could become available in the first half of 2019. The Company also plans to submit a marketing authorization application to the EMA in early 2019 with a request for conditional approval.
