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
Price :
$35
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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
- 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.