Trial Profile
A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 10 Nov 2023
Price :
$35
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At a glance
- Drugs Fruquintinib (Primary)
- Indications Colorectal cancer; Liver metastases
- Focus Registrational; Therapeutic Use
- Acronyms FRESCO
- Sponsors Hutchison MediPharma
- 09 Nov 2023 According to a HUTCHMED media release, Takeda received approval from the U.S. Food and Drug Administration ("FDA") for FRUZAQLA™ (fruquintinib), ) for previously treated metastatic colorectal cancer, based on data from FRESCO-2 and FRESCO trials.
- 15 Jun 2023 According to a Takeda media release, the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). The MAA for fruquintinib includes results FRESCO-2 and FRESCO trials.
- 25 May 2023 According to a Takeda media release, U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib based on the results of FRESCO and FRESCO-2 studies. The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.