💊Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma
NEWTON, Mass., April 10, 2018 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc.
(Nasdaq: KPTI), a clinical-stage pharmaceutical company, announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to the Company’s lead, oral Selective
Inhibitor of Nuclear Export (SINE) compound selinexor for the treatment of patients with multiple
myeloma who have received at least three prior lines of therapy. The FDA’s statement, consistent
with the design of Karyopharm’s Phase 2b STORM study, noted that the three prior lines of
therapy include regimens comprised of an alkylating agent, a glucocorticoid, Velcade®
(bortezomib), Kyprolis® (carfilzomib), Revlimid® (lenalidomide), Pomalyst® (pomalidomide) and
Darzalex® (daratumumab). In addition, the patient’s disease must be refractory to at least one
proteasome inhibitor (Velcade or Kyprolis), one immunomodulatory agent (Revlimid or Pomalyst),
glucocorticoids and to Darzalex, as well as to the most recent therapy. The Company expects to
report top-line data from the STORM study at the end of April 2018.