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A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Trial Profile

A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2024

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At a glance

  • Drugs Erdafitinib (Primary) ; Docetaxel; Pembrolizumab; Vinflunine
  • Indications Carcinoma; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms THOR
  • Sponsors Janssen; Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 27 Feb 2024 Planned End Date changed from 7 Aug 2024 to 11 Sep 2024.
    • 19 Jan 2024 According to a Johnson and Johnson media release, based upon results from this trial the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
    • 05 Dec 2023 Planned End Date changed from 26 Apr 2024 to 7 Aug 2024.
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