Takeda has received notification from the European Commission ("EC") that it has approved FRUZAQLA® (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer ("CRC") who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib. The EC's approval has been granted following a positive opinion from the Committee for Medicinal Products for Human Use ("CHMP") in April 2024. The CHMP's opinion was primarily based on results from the Phase multiregional FRESCO-2 trial, which supported the Marketing Authorisation Application ("MAA") that was validated and accepted for review in June 2023.

Data from FRESCO-2 were published in The Lancet in June 2023.