Karyopharm Fast Track for B-cell Lymphoma Drug

FDA has granted Karyopharm Therapeutics a fast track designation for selinexor, the company’s first-in-class, oral Sine compound for treating patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy. The therapy is currently being studied in the ongoing Phase 2b SADAL study in patients with relapsed or refractory DLBCL who are not eligible for stem cell transplantation.

Previously, selinexor was granted fast track as a potential new treatment for patients with penta-refractory multiple myeloma who have received at least three prior lines of therapy. Last month, FDA accepted for priority review a Karyopharm NDA for selinexor that seeks accelerated approval for this indication. The agency set a review action target date of 4/6/2019.