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A Global, Multi Center, Randomized, Placebo-Controlled Phase 3 Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care to Placebo Plus Best Supportive Care in Patients with Refractory Metastatic Colorectal Cancer (FRESCO-2)

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Trial Profile

A Global, Multi Center, Randomized, Placebo-Controlled Phase 3 Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care to Placebo Plus Best Supportive Care in Patients with Refractory Metastatic Colorectal Cancer (FRESCO-2)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2025

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At a glance

  • Drugs Fruquintinib (Primary)
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FRESCO-2
  • Sponsors Hutchison MediPharma; HUTCHMED

    • Most Recent Events

    • 20 Jan 2025 According to Takeda Canada Inc media release, the company received market authorization for FRUZAQLA from Health Canada for Metastatic Colorectal Cancer (mCRC),based on data from this trial.
    • 13 Dec 2024 According to a HUTCHMED media release, FRUZAQLA was approved in the US in November 2023, in the EU in June 2024, in Switzerland in August 2024, in Canada, Japan and the United Kingdom in September 2024 and in Argentina, Australia and Singapore in October 2024. Regulatory applications are progressing in many other jurisdictions.
    • 22 Nov 2024 According to a HUTCHMED media release, Takeda announce pricing approval and launch of fruquintinib 1mg/5mg capsules in Japan by its partner Takeda for patients with previously treated metastatic colorectal cancer. The launch of FRUZAQLA in Japan follows its approval in September 2024, primarily based on results from the Phase III FRESCO-2 trial.

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