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FDA Grants Selinexor Fast Track Designation for Relapsed/Refractory DLBCL

Gina Columbus @ginacolumbusonc
Published: Wednesday, Nov 07, 2018

The FDA has granted a fast track designation to selinexor for the treatment of patients with previously treated diffuse large B-cell lymphoma (DLBCL) who are ineligible to receive high-dose chemotherapy with stem cell rescue or chimeric antigen receptor (CAR) T-cell therapy, according to Karyopharm Therapeutics, Inc., the manufacturer of the first-in-class SINE compound.1

Selinexor is also being investigated in clinical trials across malignancies, such as the randomized phase III BOSTON trial, which is looking at selinexor in combination with bortezomib (Velcade) and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (NCT03110562). Additionally, the phase Ib/II STOMP trial is evaluating selinexor with backbone treatments—pomalidomide (Pomalyst)/dexamethasone, bortezomib/dexamethasone, lenalidomide (Revlimid)/dexamethasone, pomalidomide/dexamethasone/bortezomib, daratumumab (Darzalex) /dexamethasone, and carfilzomib (Kyprolis)/dexamethasone.

References

  1. Karyopharm. Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma. Published November 7, 2018. https://bit.ly/2Qr2pmg. Accessed November 7, 2018.
  2. Jagannath J, Vogl DT, Dimopoulos MA, et al. Phase 2b results of the STORM study: oral selinexor plus low dose dexamethasone (sd) in patients with penta-refractory myeloma (penta-MM). Clin Lymphoma Myeloma Leuk. 2018;18(suppl; Abstract MM-255). doi: 10.1016/j.clml.2018.07.149.

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