FDA Approves Use of Fruquintinib for Adult Patients With Previously-Treated Metastatic Colorectal Cancer


With this approval, fruquintinib is the first and only selective inhibitor of all 3 VEGR receptor kinases to be approved in the United States for previously treated mCRC, regardless of biomarker status.

The FDA has approved the use of fruquintinib (Fruzaqla; Takeda) for the treatment of metastatic colorectal cancer (mCRC) in adult patients who have previously received treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy, if medically appropriate. Fruquintinib is a selective oral inhibitor of VEGFR -1, -2, and -3, playing an important role in blocking tumor angiogenesis.

Further, fruquintinib was designed to have an enhanced selectivity that limits off-target kinase activity allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of a combination therapy. In addition, it has demonstrated a manageable safety profile and is currently being investigated in combinations with other anti-cancer therapies.

“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. “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 approval of fruquintinib comes after date from 2 phase 3 trials, FRESCO and FRESCO-2, which investigated fruquintinib plus best supportive care vs placebo plus best supportive care in patients with previously treated mCRC. Both trials had met their primary and key secondary efficacy endpoints, with 734 patients who were treated with fruquintinib demonstrating consistent benefit. Further, safety profiles were consistent across the trials.

"There is a pressing need for new treatments for individuals with mCRC, who have had limited options and continue to face poor outcomes. [Fruquintinib] is the first novel chemotherapy-free treatment option approved for patients in the [United States] 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. “For far too long, health care providers and patients have had limited options when selecting a therapy for mCRC. [Fruquintinib] has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”

The most common adverse events (AEs) reported following treatment with fruquintinib were hypertension, hand-foot skin reactions (eg, palmar-plantar erythrodysesthesia), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia. Further, among the 911 enrolled patients with mCRC who were treated with fruquintinib, occurrences of hypertension, hemorrhagic events, infections (eg, upper respiratory tract, urinary tract, and pneumonia), gastrointestinal perforation, hepatotoxicity, posterior reversible encephalopathy syndrome, and embryo-fetal toxicity were reported.

“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 press release. “We are encouraged to see the continued progress in providing new options to patients.”


Takeda. Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer. News release. November 8, 2023. Accessed November 9, 2023. https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Receives-US-FDA-Approval-of-FRUZAQLA-fruquintinib-for-Previously-Treated-Metastatic-Colorectal-Cancer/

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