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The FDA has approved fruquintinib (Fruzaqla) for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if 

 wild-type and medically appropriate, an anti-EGFR therapy.

The approval is based on findings from the multi-regional phase 3 FRESCO-2 (NCT04322539) and phase 3 Chinese FRESCO (NCT02314819) trials, both of which evaluated fruquintinib combined with best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC.

“Patients with metastatic disease are often fragile and fatigued—due to both their condition as well as the therapies they have been exposed to. An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating metastatic colorectal cancer,” Cathy Eng, MD, FACP, at Vanderbilt University Medical Center, said in a news release. “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized. I look forward to being able to offer a new solution to appropriate patients.”

In the FRESCO-2 trial, fruquintinib plus BSC demonstrated a median overall survival (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, 0.662; 95% CI, 0.549-0.800; 

 The addition of fruquintinib also improved progression-free survival (PFS) over the control regimen, 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; 

In the FRESCO trial, fruquintinib plus BSC led to a median OS of 9.3 months (95% CI, 8.2-10.5) vs 6.6 months (95% CI, 5.9-8.1) with placebo plus BSC (HR, 0.65; 95% CI, 0.51-0.83; 

 Fruquintinib also improved PFS compared with  placebo, with a median PFS of 3.7 months (95% CI, 3.7-4.6) and 1.8 months (95% CI, 1.8-1.8), respectively (HR, 0.26; 95% CI, 0.21-0.34; 

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes. Fruzaqla is the first novel chemotherapy-free treatment option approved for patients in the U.S. regardless of biomarker status in more than a decade,” Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, the developer of fruquintinib, said in a news release. “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer. Fruzaqla has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”

The news release also noted that the FRESCO and FRESCO-2 findings also supported the marketing authorization application in the European Union for fruquintinib, which was validated and accepted for review by the European Medicines Agency in June 2023. Additionally, in September 2023, there was a submission for the agent to the Japan Pharmaceuticals and Medical Devices Agency.

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer. Takeda. News release. November 8, 2023. Accessed November 8, 2023. 

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. 

. 2022;33(suppl 7):S1391-S1392. doi:10.1016/j.annonc.2022.08.021

Li J, Qin S, Xu R-H, et al. Effect of fruquintinib vs placebo on overall survival in patients with previously treated metastatic colorectal cancer: the FRESCO randomized clinical trial. 

. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855

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The FDA has approved fruquintinib (Fruzaqla) for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.