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A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

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Trial Profile

A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Apr 2024

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At a glance

  • Drugs Toripalimab (Primary) ; Cisplatin; Gemcitabine
  • Indications Nasopharyngeal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms JUPITER-02
  • Sponsors Shanghai Junshi Biosciences

    • Most Recent Events

    • 29 Mar 2024 According to a Junshi Biosciences Media Release, IN October 2023, the FDA approved the Biologics License Application (the "BLA") for toripalimab
    • 01 Feb 2024 According to a Junshi Biosciences Media Release, the Singapore Health Sciences Authority (HSA) has also granted priority review designation to the NDA. The NDA is supported by results from JUPITER-02 and POLARIS-02 studies. In Singapore, the NDA application was accepted by the HSA in January 2024.
    • 01 Feb 2024 According to a Junshi Biosciences Media Release, company announced that the Singapore Health Sciences Authority (HSA) had accepted the New Drug Application (NDA) for toripalimab, both in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent LA NPC, and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC as second line therapy.
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