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A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Trial Profile

A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Sep 2019

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At a glance

  • Drugs Selinexor (Primary) ; Dexamethasone
  • Indications Diffuse large B cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms SADAL
  • Sponsors Karyopharm Therapeutics
  • Most Recent Events

    • 19 Jun 2019 According to a Karyopharm Therapeutics media release, the company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2020. These submissions will include requests for accelerated approval and conditional approval, respectively.
    • 19 Jun 2019 According to a Karyopharm Therapeutics media release, the data were highlighted at the 2019 International Conference on Malignant Lymphoma (ICML).
    • 19 Jun 2019 Results published in the Karyopharm Therapeutics Media Release
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