Posted by Michael Wonder on 11 Apr 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with penta-refractory multiple myeloma
10 April 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to the company’s lead, oral selective inhibitor of nuclear export 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.
