Brand Name

Fruzaqla

Generic Name
Fruquintinib
View Brand Information
FDA approval date: November 08, 2023
Form: Capsule

What is Fruzaqla (Fruquintinib)?

For many people living with advanced colorectal cancer, treatment often involves years of managing therapies, side effects, and uncertainty. When the disease progresses despite prior treatments, patients and their families look for new options that can extend life and improve comfort. Fruzaqla (fruquintinib) is one such option, offering hope through a modern, targeted approach to controlling tumor growth. 

Fruzaqla is an oral cancer medication that belongs to a class of drugs known as vascular endothelial growth factor receptor (VEGFR) inhibitors. It works by blocking the blood vessels that supply nutrients to tumors, effectively slowing or stopping their growth. Developed by HUTCHMED and marketed by Takeda in the United States, Fruzaqla was approved by the U.S. Food and Drug Administration (FDA) in 2023 for the treatment of metastatic colorectal cancer (mCRC) that has progressed after standard chemotherapy and biologic therapies. 

As a targeted therapy, Fruzaqla represents a newer generation of anti-cancer medications designed to specifically interfere with tumor biology, helping patients manage advanced disease while maintaining a better quality of life. 

What does Fruzaqla do? 

Fruzaqla is used to treat adults with metastatic colorectal cancer whose cancer has continued to grow or spread after previous treatments. Typically, patients receiving Fruzaqla have already undergone chemotherapy with drugs such as fluoropyrimidine, oxaliplatin, and irinotecan, and have tried anti-VEGF or anti-EGFR therapies. 

The medication helps slow the progression of cancer by cutting off its blood supply, a process essential for tumor survival and growth. In clinical studies, Fruzaqla has been shown to extend overall survival and progression-free survival compared to placebo in patients who have exhausted other treatment options (FDA, 2023). 

While Fruzaqla is not a cure, it offers a way to stabilize the disease, helping patients live longer with fewer symptoms such as pain, fatigue, and weight loss. Many patients find that this treatment helps maintain a sense of control and allows for continued daily functioning, making it a valuable option in the later stages of colorectal cancer care. 

How does Fruzaqla work? 

Fruzaqla (fruquintinib) works by blocking the activity of specific enzymes called VEGF receptors (VEGFR-1, VEGFR-2, and VEGFR-3) that control the formation of new blood vessels, a process known as angiogenesis. 

Tumors rely on these newly formed blood vessels to deliver oxygen and nutrients, allowing them to grow and spread. By inhibiting VEGFRs, Fruzaqla starves the tumor of its blood supply, slowing or stopping its growth. This mechanism is particularly effective in advanced colorectal cancer, where abnormal blood vessel formation plays a key role in tumor progression. 

In simple terms, Fruzaqla helps the body “cut off the tumor’s lifeline”, reducing its ability to thrive. Unlike traditional chemotherapy that targets rapidly dividing cells throughout the body, Fruzaqla specifically targets the signaling pathways that support tumor blood vessel growth, potentially leading to fewer systemic side effects and better tolerability for patients. 

Clinically, this targeted mechanism matters because it gives doctors a precision therapy option for patients who may no longer benefit from standard chemotherapy, offering renewed hope for disease management. 

Fruzaqla side effects 

Like all cancer therapies, Fruzaqla can cause side effects. Most are manageable and can be monitored closely by the healthcare team. 

Common side effects may include: 

  • High blood pressure (hypertension) 
     
  • Fatigue or weakness 
     
  • Diarrhea 
     
  • Mouth sores (stomatitis) 
     
  • Hand-foot syndrome (redness, pain, or swelling on palms and soles) 
     
  • Loss of appetite 
     
  • Abdominal pain 
     
  • Changes in liver enzyme levels 

Serious side effects (less common) may include: 

  • Severe bleeding or blood clots 
     
  • Gastrointestinal perforation (tear in the stomach or intestines) 
     
  • Liver problems 
     
  • Heart issues such as heart failure or abnormal rhythm 
     
  • Impaired wound healing 

Fruzaqla may require temporary discontinuation before and after surgery for proper healing. Patients should seek immediate medical attention for severe abdominal pain, coughing up blood, shortness of breath, chest pain, or sudden limb swelling.  

Doctors will monitor blood pressure, liver function, and blood counts to manage side effects, which are generally reversible with timely intervention. 

Fruzaqla dosage 

Fruzaqla is an oral tablet taken once daily, usually in cycles with rest periods. Dosing is adjusted by a healthcare provider based on tolerance, lab results, and side effects. 

Doctors monitor blood pressure, heart, liver, and kidney function, and blood counts during treatment. If side effects are severe, treatment may be paused or the dose lowered.  

Dosing adjustments may be made for older adults or those with existing liver or kidney issues. Patients should take Fruzaqla as prescribed for optimal results. 

Does Fruzaqla have a generic version? 

As of 2025, Fruzaqla (fruquintinib) does not have a generic version available in the United States or internationally. It is marketed exclusively under the brand name Fruzaqla, produced by Takeda Pharmaceuticals. However, international versions may exist in other markets. 

When the patent expires, generic versions of Fruzaqla, with the same active ingredient, strength, quality, and effectiveness as the brand-name medication, may become available after FDA approval. Patients struggling to afford Fruzaqla should inquire about patient assistance programs from Takeda or independent foundations. 

Conclusion 

Fruzaqla (fruquintinib) represents a significant advancement in the treatment of metastatic colorectal cancer, especially for patients whose disease has progressed after standard therapies. By blocking the growth of blood vessels that feed tumors, it helps control cancer spread, extend survival, and maintain quality of life. 

Fruzaqla’s side effects are manageable with medical supervision and communication, ensuring safe and beneficial treatment. It offers a powerful new option for colorectal cancer patients, providing hope and time to continue their fight with strength and dignity under oncology guidance. 

References 

  1. U.S. Food and Drug Administration (FDA). (2023). FDA approves Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer. Retrieved from https://www.fda.gov 
     
  1. Mayo Clinic. (2024). Fruquintinib: Uses, side effects, and safety information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Fruquintinib oral: Drug information. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Cancer Institute (NCI). (2024). Targeted therapies for colorectal cancer. Retrieved from https://www.cancer.gov 

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A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

Summary: High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often...

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Brand Information

Fruzaqla (fruquintinib)
1INDICATIONS AND USAGE
FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) 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.
2DOSAGE FORMS AND STRENGTHS
Capsules:
  • 1 mg: size 3 hard gelatin capsule with standard yellow opaque cap and white opaque body, imprinted with “HM013” over “1 mg” on the body in black ink.
  • 5 mg: size 1 hard gelatin capsule with a red opaque cap and white opaque body, imprinted with “HM013” over “5 mg” on the body in black ink.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Hypertension
  • Hemorrhagic Events
  • Infections
  • Gastrointestinal Perforation
  • Hepatotoxicity
  • Proteinuria
  • Palmar-Plantar Erythrodysesthesia (PPE)
  • Posterior Reversible Encephalopathy Syndrome (PRES)
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS and below reflects exposure to FRUZAQLA as a single agent in 911 patients with mCRC who were enrolled in three randomized, placebo-controlled studies (FRESCO-2, FRESCO and 2012-013-00CH1) (N=781); three open-label studies (2009-013-00CH1, 2012-013-00CH3 and 2015-013-00US1) (N=124); and an open-label lead-in cohort of FRESCO-2 (N=6). Among the 911 patients who received FRUZAQLA, 23% were exposed for 6 months or longer and 3.5% were exposed for greater than one year. These patients received at least one dose of FRUZAQLA at the recommended dosage of 5 mg daily for the first 21 days of each 28-day cycle. The median age was 60 years (range: 23 to 82) and 34% were 65 years of age or older. The most common adverse reactions (incidence ≥20%) that occurred in pooled monotherapy studies were hypertension, PPE, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
Metastatic Colorectal Cancer
FRESCO-2 Study
The safety of FRUZAQLA was evaluated in FRESCO-2, a randomized, double-blind, placebo-controlled study [see . Patients received either FRUZAQLA 5 mg daily for the first 21 days of each 28-day cycle plus best supportive care (BSC) (n=456) or matching placebo plus BSC (n=230).
The median duration of therapy with FRUZAQLA was 3 months (range: 0.3 to 19.1 months).
Serious adverse reactions occurred in 38% of patients treated with FRUZAQLA. Serious adverse reactions in ≥2% of patients treated with FRUZAQLA included hemorrhage (2.2%) and gastrointestinal perforation (2.0%). Fatal adverse reaction(s) occurred in 14 (3.1%) patients who received FRUZAQLA. Fatal adverse reactions occurring in ≥2 patients include pneumonia (n=3), sepsis/septic shock (n=2), and hepatic failure/encephalopathy (n=2).
Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with FRUZAQLA. Adverse reactions leading to treatment discontinuations of FRUZAQLA in ≥1% of patients were asthenia and gastrointestinal perforation.
Dose interruptions of FRUZAQLA due to an adverse reaction occurred in 47% of patients. Adverse reactions leading to dose interruptions of FRUZAQLA in ≥2% of patients were PPE, proteinuria, asthenia, abdominal pain, hypertension, vomiting, and diarrhea.
Dose reductions of FRUZAQLA due to an adverse reaction occurred in 24% of patients. Adverse reactions leading to dose reductions of FRUZAQLA in ≥2% of patients were PPE, hypertension and asthenia.
Table 3 summarizes the adverse reactions in FRESCO-2.
Other important adverse reactions (all grades) that occurred in <10% of patients treated with FRUZAQLA included urinary tract infection (4.6%), epistaxis (3.9%), proctalgia (3.5%), pneumonia (2.4%), gastrointestinal hemorrhage (1.5%), gastrointestinal perforation (1.3%), pancreatitis (0.7%), thrombotic microangiopathy (0.2%), and posterior reversible encephalopathy syndrome (0.2%).
Table 4 provides laboratory abnormalities observed in FRESCO-2.
Other clinically relevant laboratory abnormalities (all grades) that occurred in <20% of patients treated with FRUZAQLA included pancreatic enzymes increased (3.9%).
FRESCO Study
The safety of FRUZAQLA was evaluated in FRESCO, a randomized, double-blind, placebo-controlled study [see . Patients received either FRUZAQLA 5 mg daily for the first 21 days of each 28-day cycle plus BSC (n=278) or matching placebo plus BSC (n=137).
The median duration of therapy with FRUZAQLA was 3.68 months (range: 0.3 to 22.1 months).
Serious adverse reactions occurred in 15% of patients treated with FRUZAQLA. Serious adverse reactions in ≥2% of patients included intestinal obstruction (2.9%) and hemorrhage (2.2%). Fatal adverse reaction(s) occurred in 7 (2.5%) patients who received FRUZAQLA including cerebral infarction (n=1), gastrointestinal hemorrhage (n=1), hemoptysis (n=1), bacterial infection (n=1), lung/lower respiratory infection (n=2), and multiple organ dysfunction (n=1).
Adverse reactions leading to treatment discontinuation occurred in 15% of patients who received FRUZAQLA. Adverse reactions leading to treatment discontinuations of FRUZAQLA in ≥1% were intestinal obstruction, proteinuria and hepatic function abnormalities.
Dose interruptions of FRUZAQLA due to an adverse reaction occurred in 35% of patients. Adverse reactions leading to dose interruptions of FRUZAQLA in ≥2% of patients were PPE, proteinuria, platelet count decreased, ALT increased, hypertension, and diarrhea.
Dose reductions of FRUZAQLA due to an adverse reaction occurred in 24% of patients. Adverse reactions leading to dose reduction of FRUZAQLA in ≥2% of patients were PPE, proteinuria, and hypertension.
Table 5 summarizes the adverse reactions in FRESCO.
Other clinically important adverse reactions (all grades) that occurred in <10% of patients treated with FRUZAQLA included urinary tract infection (9%), rash (9%), upper respiratory tract infection (4.7%), proctalgia (3.6%), pneumonia (2.9%), and gastrointestinal perforation or fistula (2.2%).
Table 6 provides laboratory abnormalities observed in FRESCO.
Other clinically relevant laboratory abnormalities (all grades) that occurred in <20% of patients treated with FRUZAQLA included pancreatic enzymes increased (4.3%).
5DESCRIPTION
Fruquintinib is a kinase inhibitor with the chemical name 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]-
Chemical Structure
Fruquintinib is a white to off-white powder with a dissociation constant (pK
FRUZAQLA (fruquintinib) capsules for oral administration contain 1 mg or 5 mg of fruquintinib. The inactive ingredients are corn starch, microcrystalline cellulose, and talc. The 1 mg capsule shell contains FD&C Yellow No. 5 (tartrazine), FD&C Yellow No. 6 (sunset yellow FCF), gelatin, and titanium dioxide. The 5 mg capsule shell contains FD&C Blue No. 1 (brilliant blue FCF), FD&C Red No. 40 (allura red AC), gelatin, and titanium dioxide. The printing ink for 1 mg and 5 mg capsules contains butanol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
8PRINCIPAL DISPLAY PANEL - 1 mg Capsules
NDC 63020-210-21
Rx Only
Fruzaqla
(fruquintinib) capsules
1 mg
Contains FD&C Yellow No. 5
21 capsules
Takeda
PRINCIPAL DISPLAY PANEL - 1 mg Capsules
9PRINCIPAL DISPLAY PANEL - 1 mg Capsules Label
NDC 63020-210-21
Rx Only
Fruzaqla
(fruquintinib) capsules
1 mg
21 capsules
Takeda
PRINCIPAL DISPLAY PANEL - 1 mg Capsules
10PRINCIPAL DISPLAY PANEL - 5 mg Capsules
NDC 63020-225-21
Rx Only
Fruzaqla
(fruquintinib) capsules
5 mg
21 capsules
Takeda
PRINCIPAL DISPLAY PANEL - 1 mg Capsules
11PRINCIPAL DISPLAY PANEL - 5 mg Capsules Label
NDC 63020-225-21
Rx Only
Fruzaqla
(fruquintinib) capsules
5 mg
21 capsules
Takeda
PRINCIPAL DISPLAY PANEL - 1 mg Capsules