Brand Name
Fruzaqla
Generic Name
Fruquintinib
View Brand Information FDA approval date: November 08, 2023
Form: Capsule
What is Fruzaqla (Fruquintinib)?
FRUZAQLA is indicated 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. FRUZAQLA is a kinase inhibitor indicated 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.
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A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
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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).
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 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]-
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
(fruquintinib) capsules
1 mg
Contains FD&C Yellow No. 5
21 capsules
Takeda
9PRINCIPAL DISPLAY PANEL - 1 mg Capsules Label
NDC 63020-210-21
Rx Only
Fruzaqla
(fruquintinib) capsules
(fruquintinib) capsules
1 mg
21 capsules
Takeda
10PRINCIPAL DISPLAY PANEL - 5 mg Capsules
NDC 63020-225-21
Rx Only
Fruzaqla
(fruquintinib) capsules
(fruquintinib) capsules
5 mg
21 capsules
Takeda
11PRINCIPAL DISPLAY PANEL - 5 mg Capsules Label
NDC 63020-225-21
Rx Only
Fruzaqla
(fruquintinib) capsules
(fruquintinib) capsules
5 mg
21 capsules
Takeda
