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The FDA accepts supplemental new drug application for selinexor as a treatment for R/R DLBCL

May 14, 2020

On February 19, 2020, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) filing for selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received  ≥ 2 prior therapies. Selinexor is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound that selectively binds and inhibits the nuclear export protein exportin 1 (XPO1). 1

Selinexor has previously received both orphan drug and fast track designationsfrom the FDA for the treatment of patients with relapsed or refractory DLBCL. 2This was based on the results from the SADAL study ( NCT02227251), click hereto watch John Kuruvilla discuss it.

Selinexor is approved for the treatment of relapsed and refractory multiple myeloma, and there are ongoing trials for liposarcoma and endometrial cancer.

  1. Karyopharm Therapeutics. U.S. Food and Drug Administration accepts Karyopharm’s supplemental new drug application for XPOVIO® (selinexor) as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. https://investors.karyopharm.com/news-releases/news-release-details/us-food-and-drug-administration-accepts-karyopharms-supplemental. Published Feb 19, 2020. Accessed May 12, 2020.
  2. 2.Targeted Oncology. FDA grants priority review for selinexor in R/R diffuse large B-cell lymphoma. https://www.targetedonc.com/view/fda-grants-priority-review-for-selinexor-in-rr-diffuse-large-bcell-lymphoma. Published Feb 20, 2020. Accessed May 12, 2020.