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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

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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: 21 Jan 2025

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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

    • 17 Jan 2025 According to a Johnson and Johnson media release, based on results from THOR trial, company received manufacturing and marketing approval for Balversa Tablets 3 mg,4 mg, and 5 mg for the treatment of unresectable urothelial carcinoma with FGFR3 gene mutations or fusions that have progressed after cancer chemotherapy.
    • 23 Aug 2024 According to a Johnson and Johnson media release, European Commission (EC) has approved BALVERSA(erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
    • 28 Jun 2024 According to a Johnson and Johnson media release, based on results from Cohort 1 of the Phase 3 THOR study, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for BALVERSA (erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

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