A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Trial Profile

A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2017

At a glance

  • Drugs Brentuximab vedotin (Primary) ; Bexarotene; Methotrexate
  • Indications Cutaneous T cell lymphoma; Mycosis fungoides
  • Focus Registrational; Therapeutic Use
  • Acronyms ALCANZA
  • Sponsors Takeda Oncology
  • Most Recent Events

    • 16 Aug 2017 According to a Seattle Genetics media release, the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from this phase 3 trial and two phase 2 investigator-sponsored trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). FDA has granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is December 16, 2017.
    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association
    • 20 Jun 2017 According to a Seattle Genetics media release, based on the data from this study and two phase 2 investigator-sponsored trials in patients with cutaneous T-cell lymphoma the company has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).
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