Fruzaqla (Fruquintinib) for Advanced Colorectal Cancer: A Patient Guide

"So What's Left to Try?" — Where Fruzaqla Fits in Advanced Colorectal Cancer

Written By: Nitin Goswami, Senior Medical Content Writer  |  Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)

If you're reading this, you've probably been through a lot already. Rounds of chemotherapy, maybe an infusion aimed at the tumor's blood supply, scan after scan. And now the cancer is growing again, and you're asking the question nearly everyone asks at this point: what's left?

Fruzaqla (fruquintinib) was approved for exactly this stage. It's a capsule you take at home, it isn't chemotherapy, and it doesn't depend on one particular mutation. What it does depend on is the treatment you've already had, so that's where we'll start.

The U.S. FDA approved Fruzaqla on November 8, 2023 for adults with metastatic colorectal cancer (mCRC) who have already received the standard treatments. Below we'll go through what those treatments are, what the trials found, how the medicine is taken, and the side effects your team will keep an eye on. We've also added a short list of questions you may want to take to your next appointment.

Fruzaqla at a Glance

Before Fruzaqla: What You Need to Have Tried First

What the Approval Says, in Plain Words

Fruzaqla is meant for adults whose metastatic colorectal cancer has already been treated with all of the following:

• Chemotherapy that includes a fluoropyrimidine (5-FU or capecitabine, for example), oxaliplatin, and irinotecan
• An anti-VEGF therapy, which is a biologic medicine aimed at the tumor's blood-vessel growth
• An anti-EGFR therapy, too, if your tumor is RAS wild-type and that treatment was medically appropriate for you

Do You Need a Special Test First?

• Not for Fruzaqla itself. It isn't tied to a specific mutation, so there's no companion test that has to come back positive before it can be prescribed
• Your RAS status still matters, though, because it decides whether an anti-EGFR therapy should have been part of your earlier treatment
• If your tumor carries a KRAS G12C mutation, there is a different targeted option, which we cover in our guide to the KRAS G12C mutation and Lumakras

Who Was in the Main Trial?

The main trial, called FRESCO-2, enrolled people who had already been treated a great deal, and that's worth keeping in mind when you compare their results to your own situation.

• On average they had received 4 earlier lines of treatment for metastatic disease, and 73% had received more than 3 lines
• Everyone had already had fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and 96% had also had an anti-VEGF therapy
• 91% had received trifluridine/tipiracil, 48% had received regorafenib, and 39% had received both

Colorectal Cancer in Numbers

Numbers can feel cold when it's your own diagnosis, but they do show one thing clearly: you are far from the only person dealing with this. Every figure below names its source and year, so you can look it up yourself.

How Many People Are Affected?

• Worldwide (GLOBOCAN 2024, WHO/IARC): 2,041,007 new cases and 917,895 deaths in a year. It's the 3rd most common cancer (9.9% of all cancers) and the 2nd leading cause of cancer death (9.4%)
• India (GLOBOCAN 2024): 83,577 new cases and 38,499 deaths a year, which works out to about 230 people diagnosed every day. It's India's 4th most common cancer (5.3% of all cancers)
• United States (SEER, 2026 estimate): 158,850 new cases and 55,230 deaths, with an estimated 1.48 million people living with colorectal cancer in 2023

India's figures are modelled from regional cancer registries rather than counted nationwide, so treat them as a reliable ballpark, not an exact head-count.

Who Gets It?

• In India it's the 3rd most common cancer in men (48,536 cases, 6.2% of cancers in men) and the 5th most common in women (35,041 cases, 4.5% of cancers in women), according to GLOBOCAN 2024
• In the US, the median age at diagnosis is 66 (SEER, 2019–2023)
• About 3.9% of people in the US will be diagnosed at some point in their lives (SEER, 2021–2023 data)

Why the Stage Matters So Much

• In the US, 34% of cases are found while still confined to the colon or rectum, 37% have reached nearby lymph nodes, and 23% have already spread to distant organs (SEER, 2016–2022)
• Five-year survival is about 91% when the cancer is localized, 75% when it's regional, and 17% once it has spread to distant organs. Across all stages it's 65%

These are relative survival figures, meaning they compare people with the cancer to the general population, and they describe large groups rather than any one person. If you'd like a refresher on how staging works, our guide to cancer types, stages, and treatment walks through it. The low survival at the distant stage is a big reason later-line treatments are studied so closely.

How Fruquintinib Works, Without the Jargon

Cutting Off the Tumor's Supply Line

Tumors depend on new blood vessels (angiogenesis) to grow and spread, and they encourage the body to build them using chemical signals called VEGF. Those signals act through receptors called VEGFR-1, VEGFR-2, and VEGFR-3. Fruquintinib is a kinase inhibitor that blocks all three receptors, so the tumor's call for new blood vessels goes unanswered.

How It Differs From the Anti-VEGF Treatment You May Already Have Had

• Your earlier anti-VEGF therapy is a biologic medicine, usually given by infusion, that interferes with the VEGF pathway
• Fruquintinib is a small-molecule capsule you swallow, and it blocks the VEGF receptors themselves, all three of them
• It's a different kind of drug working on the same pathway from another angle, so it has its own side effects, which is why the monitoring list further down is a long one

What the Trials Found

FRESCO-2: The Global Trial (691 Patients)

FRESCO-2 was an international, double-blind, placebo-controlled trial run at 124 hospitals in 14 countries (The Lancet, 2023). Patients received either Fruzaqla 5 mg (461 patients) or a placebo capsule (230 patients). Both groups also got best supportive care, which means help with symptoms but no anticancer drug.

How Long People Lived

• Median overall survival was 7.4 months with Fruzaqla and 4.8 months with placebo. That's about 2.6 months longer, and it translates to a hazard ratio for death of 0.66, or roughly a third lower risk of death
• Median progression-free survival, the time before the cancer grew again, was 3.7 months versus 1.8 months (hazard ratio 0.32)

How Well People Tolerated It

• Grade 3 or worse side effects occurred in 63% of patients on Fruzaqla and 50% on placebo
• The most common grade 3 or worse effects were high blood pressure (14%), weakness or fatigue (8%), and hand-foot syndrome (6%)
• According to the FDA label, 20% of patients stopped treatment because of side effects, 47% had a dose interruption, and 24% had their dose reduced

FRESCO: The Earlier Trial in China (416 Patients)

• This trial ran at 28 hospitals in China and enrolled people whose cancer had progressed after at least 2 chemotherapy regimens (JAMA, 2018)
• Median overall survival was 9.3 months versus 6.6 months (hazard ratio 0.65), and median progression-free survival was 3.7 months versus 1.8 months
• Grade 3 or 4 side effects occurred in 61.2% of the Fruzaqla group versus 19.7% on placebo
• The authors pointed out that more research was needed to know whether the results held outside China, which is what the global FRESCO-2 trial went on to test

So How Much Does It Actually Help?

Let's say it plainly. In the global trial, Fruzaqla gave a median of about 2.6 extra months in people who had already been through many treatments. That's a real gain, and it is also a modest one. It is not a cure.

• A median is a midpoint for a group, so some people do better than average and some do worse
• The trial compared Fruzaqla with a placebo, not with the other late-line drugs, so it can't tell you which of them is the best fit for you
• The benefit has to be weighed against the side effects. Nearly half of patients needed at least one interruption of treatment

Whether it's worth it depends on how you're feeling, how you handled earlier treatments, and what matters most to you right now. That conversation belongs with your oncologist.

Taking Fruzaqla Day to Day

The Schedule: Three Weeks On, One Week Off

• Dose: 5 mg once a day for the first 21 days of every 28-day cycle, then 7 days off
• Timing: around the same time each day, with or without food
• Swallow it whole: please don't open or chew the capsules
• Capsules: they come in 1 mg and 5 mg strengths, and each bottle holds 21 capsules
• How long: until the disease progresses or side effects become unacceptable. In FRESCO-2 the median treatment time was 3 months

Missed a Dose? Vomited? Storage Questions

• Missed dose: take it only if less than 12 hours have passed since the scheduled time. Never take two doses on the same day to make up for one
• Vomiting after a dose: don't take an extra one, just carry on with the next scheduled dose
• Storage: keep the capsules at room temperature, 20°C to 25°C (68°F to 77°F). Brief exposure between 15°C and 30°C is fine

If Side Effects Get in the Way

• The first step down is 4 mg once daily
• The second step down is 3 mg once daily
• If you can't tolerate 3 mg, treatment is stopped for good

Side Effects and What Your Team Will Watch

Fruzaqla has no contraindications on its label, but it does come with a set of warnings that are typical of drugs that block VEGF receptors. These are the main ones.

High Blood Pressure

How Common Is It?

• Across 911 patients treated in the clinical studies, 49% developed high blood pressure, and 19% had grade 3 to 4 events. In FRESCO-2 alone the figure was 38%, with 14% at grade 3 or 4
• A hypertensive crisis occurred in 3 patients (0.3%)
• It typically shows up early: the median time to first onset was 14 days after the first dose

What the Monitoring Looks Like

Before You Start

Fruzaqla shouldn't be started until your blood pressure is well controlled.

While You're on Treatment

Your blood pressure is checked weekly for the first month and at least monthly after that, and your blood pressure medicine is started or adjusted as needed. Keeping a simple notebook of your readings can make those visits much easier.

If Your Blood Pressure Stays Very High

• Grade 3 hypertension that persists despite the best blood pressure treatment: Fruzaqla is paused, then restarted at the next lower dose once it settles
• Grade 4 hypertension: Fruzaqla is stopped permanently

Hand-Foot Skin Reaction (Palmar-Plantar Erythrodysesthesia)

• It occurred in 35% of patients, with 8% at grade 3. The median time to onset was 19 days
• Grade 2: treatment is paused, you get supportive care, and you restart at the same dose once it improves to grade 1
• Grade 3: treatment is paused, then restarted at the next lower dose

Liver Function

• Raised liver enzymes (ALT or AST) occurred in 48% of patients, with 5% at grade 3 or higher and fatal events in 0.2%. The median onset was 29 days
• Liver tests (ALT, AST, and bilirubin) are done before you start and periodically afterward
• Treatment is paused for significant enzyme rises, and stopped for good if the enzymes are raised together with a high bilirubin

Protein in the Urine

• It occurred in 36% of patients, with 2.5% at grade 3 or higher. The median onset was 22 days
• Urine protein is checked before you start and periodically afterward
• Treatment is paused at 2 grams or more of protein per 24 hours, and stopped permanently for nephrotic syndrome

Bleeding, Perforation and Infection

• Bleeding: gastrointestinal bleeding occurred in 6% of patients, with 1% at grade 3 or higher and 2 fatal events. If you're on blood thinners, your INR is monitored, and severe bleeding means treatment is stopped permanently
• Gastrointestinal perforation: a grade 3 or higher event occurred in 1.3% of patients, including one fatal case. Any perforation or fistula means stopping for good
• Infections: these were more common than with placebo (18% versus 12%), and so were fatal infections (1% versus 0.3%). Treatment isn't started during an active infection and is paused for serious ones

If You Have Surgery Planned

• Drugs that block VEGF can slow down wound healing
• Don't take Fruzaqla for at least 2 weeks before major surgery, or for at least 2 weeks after it and until the wound has healed properly. Do tell your surgeon you're on it

Other Things to Know

• PRES (posterior reversible encephalopathy syndrome): this is rare. Seizures, headache, vision changes, or confusion need urgent evaluation, and treatment is stopped if it's confirmed
• Arterial blood clots: these occurred in 0.8% of patients, so starting Fruzaqla soon after a clot needs careful thought
• Color additives: the 1 mg capsules contain FD&C Yellow No. 5 (tartrazine) and No. 6, which can cause allergic-type reactions in some people, particularly those with aspirin hypersensitivity

The Most Common Side Effects at a Glance

These were the most frequent side effects in FRESCO-2 (all grades), with the placebo comparison where the label gives one:

• Fatigue: 53% (39% on placebo)
• High blood pressure: 38% (9% on placebo)
• Mouth sores (stomatitis): 31%
• Abdominal pain: 25%
• Diarrhea: 24%
• Underactive thyroid: 21%
• Hand-foot skin reaction: 19%
• Protein in the urine: 18%
• Hoarseness or a change in your voice (dysphonia): 18%

Other Medicines You Take

• Strong CYP3A inducers should be avoided, because they can lower fruquintinib levels and weaken its effect
• Moderate CYP3A inducers should be avoided if possible. If that isn't possible, the usual dose is continued
• Tell your oncologist about everything you take, including supplements

Pregnancy and Breastfeeding

• Fruzaqla can cause fetal harm. Women who could become pregnant, and men whose partners could become pregnant, should use effective contraception during treatment and for 2 weeks after the last dose
• Breastfeeding isn't advised

Questions Worth Taking to Your Next Appointment

You don't have to remember everything in this article. Here are a few questions that can get the conversation started:

• Has my tumor's RAS status been checked, and did it change which treatments I should have had?
• Is my blood pressure controlled well enough to start?
• Do I have any surgery coming up that we should plan around?
• How often will I need blood pressure, liver, and urine checks?
• Which side effects should make me call you straight away?
• What happens if I need to lower the dose?

Getting Fruzaqla in India

The regulated route for an individual patient is a Named Patient Program, which imports a medicine for one specific patient against a doctor's prescription. Through NPP, Fruzaqla is sourced directly from Takeda's authorized supply chain. In practice, you'll need:

• A valid prescription from your treating oncologist
• Confirmation of your metastatic colorectal cancer diagnosis and your prior treatment history
• Supporting clinical documentation, as required by Indian regulatory authorities

The Fruzaqla product page explains the process, and our oncology access program covers other cancer medicines on the same pathway.

Have Your Reports Handy? Let's Look at Your Options Together

Whether Fruzaqla fits you comes down to your treatment history: which chemotherapies you've had, whether you received an anti-VEGF therapy, and, if your tumor is RAS wild-type, an anti-EGFR therapy. Send our team your reports along with your oncologist's recommendation, and we'll explain what the access process would involve. There's no cost and no obligation. Start the conversation here.

The Short Version

• Fruzaqla (fruquintinib) is an oral VEGFR-1/2/3 inhibitor capsule, approved by the FDA on November 8, 2023 for metastatic colorectal cancer after chemotherapy, an anti-VEGF therapy, and (if RAS wild-type) an anti-EGFR therapy.
• Colorectal cancer is the 3rd most common cancer worldwide and the 4th most common in India, with 83,577 new cases a year (GLOBOCAN 2024).
• In the global FRESCO-2 trial, median survival was 7.4 months versus 4.8 months with placebo. It's a real but modest gain in a heavily pretreated group.
• The dose is 5 mg daily for 21 days of each 28-day cycle, with steps down to 4 mg and 3 mg if side effects call for it.
• Blood pressure, liver tests, and urine protein are checked regularly, and treatment has to pause around major surgery.
• Contraception is needed during treatment and for 2 weeks after the last dose.
• Fruzaqla can be accessed through a Named Patient Program with your oncologist's prescription and treatment records.

Frequently Asked Questions

Is Fruzaqla chemotherapy?

No. Chemotherapy attacks fast-dividing cells all over the body. Fruzaqla is a targeted capsule that blocks three specific receptors, VEGFR-1, -2, and -3, which tumors use to build new blood vessels.

What should I realistically expect from it?

In the global trial, people on Fruzaqla lived a median of 7.4 months compared with 4.8 months on placebo, and their cancer took longer to grow again (3.7 months versus 1.8 months). It isn't a cure, and individual results vary a lot around those medians.

My blood pressure is high. Can I still take it?

Your blood pressure needs to be well controlled before you start, so in practice the first step is usually getting it under control. Your oncologist and your regular doctor can work that out together, and once you're on treatment it's checked weekly for the first month.

Do I have to stop it before an operation?

Yes. The label says not to take it for at least 2 weeks before major surgery, and not for at least 2 weeks afterward and until the wound has healed properly. Let your surgeon know you're taking it.

How long will I be on it?

Until the cancer progresses or the side effects become unacceptable. The usual pattern is 3 weeks on and 1 week off in each 28-day cycle, and in the global trial the median treatment time was 3 months.

Does my RAS test result decide whether I can have Fruzaqla?

Not directly. RAS status determines whether an anti-EGFR therapy should have been part of your earlier treatment. If your tumor is RAS wild-type and an anti-EGFR was medically appropriate, it should have been tried first.

How do I get Fruzaqla in India?

Through a regulated Named Patient Program. It imports the medicine for a specific patient, with a valid prescription from the treating oncologist, confirmation of your diagnosis and prior treatment history, and supporting clinical documentation.

Is it safe to order it from an online pharmacy or a seller abroad?

Please be careful here. Cancer medicines sold outside regulated channels can be counterfeit, expired, or stored badly, and a capsule that looks right tells you nothing about what's inside it. Named Patient Program sources Fruzaqla from Takeda's authorized supply chain, against a valid oncologist's prescription, with documentation and batch traceability, so what reaches you can be traced back to the manufacturer.

Every colorectal cancer journey looks a little different, and the right next step depends on your history, your test results, and how you're feeling. Use this page to prepare better questions, and let your oncologist make the final call.

References

1. U.S. Food and Drug Administration. FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer, November 8, 2023.
2. DailyMed (National Library of Medicine). FRUZAQLA (fruquintinib) Prescribing Information.
3. Dasari A, et al. Fruquintinib versus Placebo in Patients with Refractory Metastatic Colorectal Cancer (FRESCO-2), The Lancet 2023;402.
4. Li J, 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.
5. National Cancer Institute SEER Program. Cancer Stat Facts: Colorectal Cancer.
6. International Agency for Research on Cancer (WHO). GLOBOCAN 2024: World Fact Sheet.
7. International Agency for Research on Cancer (WHO). GLOBOCAN 2024: India Fact Sheet.