Selinexor Gets FDA Fast-Track Status for Penta-Refractory Myeloma Patients
Karyopharm Therapeutics recently announced that their oral drug selinexor (Selective Inhibitor of Nuclear Export) is obtaining FDA fast-track status for myeloma patients who have received three prior lines of therapy. Those three lines must have included five different drug classes:
- Chemotherapy like melphalan or cyclophosphamide
- A proteasome inhibitor like bortezomib or carfilzomib
- An immunomodulator like lenalidomide or pomalidomide
- A steroid like dexamethasone
The FDAs statement is based on results from Karyopharms Phase 2b STORM study. According to Sharon Shacham, MD, PhD, Founder, President and Chief Scientific Officer of Karyopharm:
The designation of Fast Track for selinexor represents important recognition by the FDA of the potential of this anti-cancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies. We are fully committed to working closely with the FDA as we continue development of this potential new, orally-administered treatment for patients who currently have no other treatment options of proven benefit.
To find all selinexor clinical trials, click below:
Selinexor Clinical Trials
To learn how selinexor works, watch the video below with Dr. David Siegel of the John Theurer Cancer Center.