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FDA Approves New Chemotherapy-Free Treatment Option for Metastatic Colorectal Cancer


Fruquintinib (Fruzaqla) is the first novel chemotherapy-free treatment option approved for metastatic colorectal cancer in more than a decade.

The FDA has approved fruquintinib (Fruzaqla) to treat adults with metastatic colorectal cancer who received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy for cases that are RAS wild-type and medically appropriate.1

Image credit: Dr_Microbe | stock.adobe.com

Image credit: Dr_Microbe | stock.adobe.com

Fruzaqla is an oral, highly selective, small molecule VEGF receptor inhibitor. Because of the kinase selectivity of Fruzaqla, the risk of off-target toxicity is less than the risk with multikinase inhibitors, including regorafenib.2

"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 US regardless of biomarker status in more than a decade,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, in a press release.1 “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.”

Colorectal cancer is the third most common type of the disease worldwide, with an estimated 915,000 deaths globally in 2020. Last year, researchers estimated that 151,000 people in the United States were diagnosed with colorectal cancer, as data show that more than one-third of these patients died.3

Further, it is the second most common type of cancer in Europe, with approximately 507,000 new cases diagnosed in 2020, of which approximately 47% resulted in mortality. Colorectal cancer is also the most common type of cancer in Japan, with 147,000 new cases diagnosed in 2020. All of these data highlight the need for effective new treatments.

“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,” said Cathy Eng, MD, FACP, at Vanderbilt University Medical Center, in a press release.1 “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.”

The FDA based the regulatory action on findings from the multi-regional phase 3 FRESCO-2 trial (NCT04322539) and the phase 3 Chinese FRESCO (NCT02314819) trial. These trials both compared Fruzaqla plus best supportive care (BSC) vs. placebo plus BSC in patients with previously treated metastatic colorectal cancer.

FRESCO-2 data show that Fruzaqla plus BSC produced a median overall survival (OS) of 7.4 months vs. 4.8 months in patients administered a placebo.4 Adding Fruzaqla was found to improve progression-free survival (PFS) compared to the control cohort, at a median of 3.7 months vs. 1.8 months, respectively.

Data from the FRESCO trial show that Fruzaqla plus BSC produced a median OS of 9.3 months compared with 6.6 months in the placebo plus BSC cohort.5 For PFS, patients administered Fruzaqla had a median of 3.7 months compared with 1.8 months with the placebo.

“We have witnessed firsthand the physical and emotional toll metastatic colorectal cancer has on patients, their families and their care teams,” said Michael Sapienza, chief executive officer, at Colorectal Cancer Alliance, in the release.1 “We are encouraged to see the continued progress in providing new options to patients.”


1. Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer. Takeda. News release. November 8, 2023. Accessed November 9, 2023.

2. Shirley M. Fruquintinib: first global approval. Drugs. 2018;78(16):1757-1761. doi:10.1007/s40265-018-0998-z. Accessed November 9, 2023.

3. HUTCHMED Highlights Phase III FRESCO-2 MRCT Data Summary of Fruquintinib in Refractory Metastatic Colorectal Cancer from the Upcoming ESMO 2022 Presentation. Globe Newswire. September 7, 2022. Accessed November 9, 2023.

4. 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. Accessed November 9, 2023.

5. 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. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855. Accessed November 9, 2023.

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