Fruquintinib Receives Positive CHMP Opinion for Previously Treated mCRC


CHMP has voiced its support for the approval of fruquintinib in previously treated metastatic colorectal cancer.

Awny Farajallah, MD

Awny Farajallah, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib (Fruzaqla) for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC).1

This positive opinion was based on results from the multi-regional phase 3 FRESCO-2 trial (NCT04322539), which investigated fruquintinib with best supportive care (BSC; n = 461) vs placebo plus BSC (n = 230) in patients with previously treated mCRC. Findings from the study demonstrated a significant benefit in both overall survival (OS) and progression-free survival (PFS) with the addition of fruquintinib.1,2 Treatment with fruquintinib and BSC resulted in a median OS of 7.4 months (95% CI, 6.7-8.2) compared with 4.8 months (95% CI, 4.0-5.8) in the placebo arm (HR, 0.66; 95% CI, 0.55-0.80; P < .0001).2

Furthermore, fruquintinib showed an improvement in PFS over placebo, at a median of 3.7 months (95% CI, 3.5-3.8) and 1.8 months (95% CI, 1.8-1.9), respectively (HR, 0.321; 95% CI, 0.267-0.386; P < .0001).3 The trial met all of its primary and key secondary efficacy end points and showed consistent benefit among patients treated on the fruquintinib arm, regardless of the prior types of therapies received; these findings were both statistically significant and clinically meaningful.1

“People living with mCRC in the European Union [EU] currently have limited treatment options, which can lead to poor outcomes” Awny Farajallah, MD, chief medical officer, Global Oncology, Business Unit, at Takeda, stated in the news release. “With this positive opinion for fruquintinib, we are one step closer to potentially offering patients a new, oral, chemotherapy-free option that may provide a survival benefit. We look forward to the European Commission’s official decision in the near future as we work to redefine the treatment landscape and help address a significant unmet need for those affected by mCRC.”

Fruquintinib is a selective inhibitor of VEGFR-1, –2, and –3, and, if approved, the agent will be the first and only selective inhibitor of all 3 VEGFRs approved in the EU for patients with previously treated mCRC, as well as the first novel targeted therapy approved for this patient population–regardless of biomarker status–in over a decade.1

Notably, fruquintinib was approved by the FDA in November 2023 for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy (if medically appropriate); this approval was also supported by data from FRESCO-2 in addition to the phase 3 Chinese FRESCO trial (NCT02314819).4

The FRESCO-2 trial evaluated patients with mCRC who had received prior chemotherapy containing fluoropyrimidine, oxaliplatin, or irinotecan, as well as VEGF and EGFR inhibitors if they had RAS wild-type disease. Eligibility required progression on or intolerance to trifluridine/tipiracil (Lonsurf; TAS-102) and/or regorafenib (Stivarga).1

Regarding safety, the agent demonstrated a manageable safety profile in FRESCO-2. Twenty percent of patients demonstrated adverse events (AEs) that led to treatment discontinuation following treatments with fruquintinib plus BSC vs 21% of patients who discontinued treatment following placebo plus BSC.1

Data from FRESCO-2 supported the EMA's decision to validate and accept a marketing authorization application for priority review of fruquintinib for the treatment of adult patients with pretreated mCRC in June 2023.5


  1. Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer. News release. Takeda. April 26, 2024. Accessed April 26, 2024.
  2. Dasari A, Lonardi S, Garcia-Carbonero R, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9
  3. Dasari NA, Lonardi S, Garcia-Carbonero R, et al. LBA25 FRESCO-2: a global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022;33(suppl 7):S1391-S1392. doi:10.1016/j.annonc.2022.08.021
  4. FDA approves fruquintinib in refractory metastatic colorectal cancer. FDA. News release. November 8, 2023. Accessed April 26, 2024.
  5. Takeda and HUTCHMED announce marketing authorization application of fruquintinib for previously treated metastatic colorectal cancer validated by the European Medicines Agency. News release. June 15, 2023. Accessed April 26, 2024.
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