How can FRUZAQLA^® (fruquintinib) help?

FRUZAQLA was studied across 2 clinical trials that included more than 1100 people

The 2 studies were called FRESCO and FRESCO-2. FRESCO was a single-country study, while FRESCO-2 was a global study. Because FRESCO-2 included adults with metastatic colorectal cancer (mCRC) from several countries we are focusing on these results. It compared people taking FRUZAQLA plus best supportive care* with people taking placebo (sugar pill) plus best supportive care.

People in FRESCO-2 were between 25 and 86 years old. The median^† age was 64 years. They had all received chemotherapy in the past.

The FRESCO-2 study measured a few things about FRUZAQLA, including:

Do people live longer with FRUZAQLA compared with placebo?

Does it take longer for people's mCRC to get worse with FRUZAQLA compared with placebo?

How safe is FRUZAQLA?

*Best supportive care (or BSC) focuses on managing stage 4 colon cancer symptoms and keeping you as well as possible. It may include things like counseling or pain management.

^†Median=the midpoint value of a range of values.

Current metastatic colorectal cancer treatment guidelines recommend FRUZAQLA (fruquintinib) as a potential treatment option for previously treated mCRC

Download the Current Treatment Guidelines

Results with FRUZAQLA

Learn about the clinical trial results of FRUZAQLA from Dr. Al Hallak, a GI medical oncologist.

ViewHide Transcript

Dr. Al Hallak
FRUZAQLA is a prescription medicine used to treat adults with colon or rectal cancer that has spread to other parts of the body, and who have received previous treatment with certain anti-cancer medicines.

It is not known if FRUZAQLA is safe and effective in children.

I prescribe FRUZAQLA to patients with colon or rectal cancer that spread to another organ, means stage four disease. That would either went through the available chemotherapy options along with some targeted therapy options available for them or unfortunately were not able to go through those treatments due to side effects. Those patients usually we consider them in the second line or third line and beyond where they are searching for other treatment options for their cancer.

In Fresco-2 trial patients who took FRUZAQLA lived longer than those patients that took placebo means the sugar pill.

The median overall survival for patients taking FRUZAQLA in the clinical trial was 7.4 months compared to placebo, which was 4.8 months. That means there was 2.6-month improvement in the survival in the FRUZAQLA arm. In a different way, patients who took FRUZAQLA in the clinical trial had 34% more likelihood of living longer.

In Fresco two trial people taking FRUZAQLA went more than twice as long without their colon cancer getting worse compared to those taking placebo, means sugar pill. In the trial it was observed that the median progression-free survival for patients taking FRUZAQLA along with best supportive care was 3.7 months compared to 1.8 months in the placebo arm. That means there was 1.9 months improvement in those patients taking FRUZAQLA plus best supportive care compared to placebo.

In a different way, we tell patients that when you take FRUZAQLA it will improve your chance of not getting the colon cancer worse by 68%.

FRUZAQLA is an oral target therapy. It is not chemotherapy, and it will help you to fight the colon cancer. FRUZAQLA is an oral option that you can take at home, so you don't have to worry about coming to the infusion center. You can also take FRUZAQLA if you're traveling to continue the treatment of the colon cancer while you are abroad.

The most common side effects of FRUZAQLA reported in the clinical trial that led to the FDA approval are voice changes or hoarseness, abdominal pain, diarrhea, weakness, lack of strength and energy, and feeling very tired or sleepy.

In my experience, the most common side effects I have seen from FRUZAQLA in my clinical practice are tiredness, hoarseness in the voice and dryness in the hands and feet.

How to take FRUZAQLA

Learn more about dosage and keeping track of your dosing schedule.

Get dosing information

Side effects with FRUZAQLA

Explore the potential common side effects while taking FRUZAQLA.

Read about side effects

How FRUZAQLA works

Discover what makes FRUZAQLA different.

Explore how it works

IMPORTANT SAFETY INFORMATION

FRUZAQLA may cause serious side effects, including:

High blood pressure (hypertension). High blood pressure is common with FRUZAQLA and can also be severe. Your healthcare provider will check your blood pressure before starting treatment with FRUZAQLA, 1 time every week for the first month of treatment, and then at least 1 time a month or more often if needed during treatment. Your healthcare provider may prescribe medicine to treat your high blood pressure if needed. Tell your healthcare provider if you get any of the following symptoms of hypertension during treatment: severe headache, lightheadedness or dizziness, confusion, changes in vision, chest pain, trouble breathing, nosebleeds, or vomiting.

Severe bleeding (hemorrhage). FRUZAQLA can cause bleeding that can be serious and may lead to death. Tell your healthcare provider if you get any of the following symptoms of bleeding during treatment:

unusual, severe, or bleeding that will not stop
bruising
lightheadedness
vomiting blood or your vomit looks like coffee grinds
blood in the stool or black stool that looks like tar
blood in the urine or urine that looks red, pink, or brown
coughing up blood or blood clots
menstrual bleeding that is heavier than normal
unusual vaginal bleeding
nose bleeds that happen often

Infections. FRUZAQLA can increase the risk of infections, including serious infections that can lead to death. The most common infections with FRUZAQLA happened in the urinary tract, nose or throat, and lungs. Tell your healthcare provider if you get any of the following symptoms of infection during treatment: fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, trouble breathing, burning or pain when you urinate, or redness, swelling, or pain in any part of the body.

A tear in your stomach or intestinal wall (gastrointestinal perforation). FRUZAQLA can cause gastrointestinal perforation that can be serious and may lead to death. Tell your healthcare provider right away if you get any of the following symptoms of gastrointestinal perforation during treatment: severe stomach (abdominal) pain or stomach pain that does not go away, vomiting or vomiting blood, blood in the stool or black stool that looks like tar, fever or chills, or nausea.

Liver problems. Increased liver enzymes in your blood are common with FRUZAQLA and can also be severe and may lead to death. Your healthcare provider will do blood tests before and during treatment with FRUZAQLA to check for liver problems. Tell your healthcare provider if you get any of the following symptoms of liver problems during treatment: yellowing of your skin or the white part of your eyes, dark-colored (tea-colored) urine, pain in your right upper stomach area (abdomen), loss of appetite, nausea or vomiting, or bleeding or bruising.

Protein in your urine (proteinuria). Protein in your urine is common with FRUZAQLA and can also be severe. Your healthcare provider will check your urine for protein before starting and during treatment with FRUZAQLA. Tell your healthcare provider if you have to urinate more than usual or if you get swelling of your face, hands, arms, legs, or feet during treatment.

Hand-foot skin reactions (Palmar-Plantar Erythrodysesthesia [PPE]). Hand-foot skin reactions are common with FRUZAQLA and can also be severe. Tell your healthcare provider if you get a severe rash or redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a serious condition that can happen in your brain during treatment with FRUZAQLA. Tell your healthcare provider right away if you get any of the following symptoms during treatment: headache, seizures, confusion, changes in vision, or problems thinking.

Wound healing problems. Wounds may not heal properly during treatment with FRUZAQLA. Tell your healthcare provider if you plan to have any surgery before starting FRUZAQLA or during treatment. You should stop taking FRUZAQLA at least 2 weeks before planned surgery. Your healthcare provider will tell you when you may start taking FRUZAQLA again after surgery.

Blood clots in your blood vessels (arteries). FRUZAQLA can cause blood clots or blockage in your blood vessels that may lead to heart attack, stroke, or death. Get medical help right away if you get any of the following symptoms during treatment:

severe chest pain or pressure
pain in your arms, legs, back, neck or jaw
shortness of breath
numbness or weakness of your face, arm, or leg, especially on one side of your body
feeling lightheaded or faint
sweating more than usual
sudden confusion, trouble talking or understanding things
trouble walking
sudden severe headache
sudden vision changes in one or both eyes
dizziness or loss of balance or coordination

Allergic reactions to FD&C Yellow No. 5 and FD&C Yellow No. 6. FRUZAQLA 1mg capsules contain the inactive ingredients FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (sunset yellow FCF). FD&C Yellow No. 5 (tartrazine) can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin. FD&C Yellow No. 6 (sunset yellow FCF) can also cause allergic reactions. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with FRUZAQLA.

The most common side effects of FRUZAQLA include:

voice changes or hoarseness

stomach-area (abdominal) pain

diarrhea

weakness, lack of strength and energy, and feeling very tired or sleepy (asthenia)

FRUZAQLA may cause fertility problems in females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of FRUZAQLA. Call your doctor for medical advice about side effects. You may report side effects to Takeda at 1-844-662-8532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking FRUZAQLA, tell your healthcare provider about all your medical conditions, including if you:

Have high blood pressure.

Have bleeding problems

Have an infection

Have liver or kidney problems

Plan to have surgery or have had recent surgery. You should stop taking FRUZAQLA at least 2 weeks before your planned surgery. Your healthcare provider will tell you when you can start FRUZAQLA again after your surgery

Have recently had a blood clot, stroke, or heart attack

Are allergic to FD&C Yellow No. 5 (tartrazine) or FD&C Yellow No. 6 (sunset yellow FCF)

Are pregnant or plan to become pregnant. FRUZAQLA can harm your unborn baby. You should not become pregnant during treatment with FRUZAQLA.

Females who can become pregnant:

Your healthcare provider will do a pregnancy test before you start treatment with FRUZAQLA.
Use effective birth control (contraception) during treatment and for 2 weeks after your last dose of FRUZAQLA.
Tell your healthcare provider right away if you become pregnant during treatment with FRUZAQLA.

Males with female partners who can become pregnant:

Use effective birth control during treatment and for 2 weeks after your last dose of FRUZAQLA.
Tell your healthcare provider right away if your partner becomes pregnant during your treatment with FRUZAQLA.

Are breastfeeding or plan to breastfeed. It is not known if FRUZAQLA passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of FRUZAQLA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FRUZAQLA may affect the way other medicines work, and other medicines may affect how FRUZAQLA works.

Especially tell your healthcare provider if you take blood thinners (anticoagulants).

Know the medicines you take. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.