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A new drug to treat colorectal cancer now approved in Europe

Marina Virko
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Johannes Grossmann

The European Medicines Agency has approved a new drug for the treatment of bowel cancer. It is a targeted substance that aims only at certain receptors on the tumor, inhibiting its growth.

The new drug is an urgent need

Colorectal cancer, also known as colorectal carcinoma, is a very common malignant disease. It is what is usually meant when a diagnosis of colon cancer is mentioned. It affects the large intestine and rectum, that is, the final part of the digestive system.

In the early stages, the disease can often be cured with surgery and drug therapy. However, the prognosis for metastasizing tumors is usually unfavorable. Therefore, today there is an urgent need for new and more effective treatments for progressive forms of this malignancy.

Thus, the introduction of fruquintinib, a highly selective and potent drug that shows good results at advanced stages, is undoubtedly good news for millions of colon cancer patients.

Fruquintinib action mechanism: inhibition of tumor angiogenesis

Fruquintinib, sold under the trade name Fruzaqla® by Takeda, is a novel tyrosine kinase inhibitor, taken in tablet form, that specifically targets vascular endothelial growth factors (VEGFR-1, -2 and -3). These receptors play a central role in angiogenesis, that is, the process of blood vessel formation in tumors. Blocking these receptors prevents the formation of new blood vessels, thereby suppressing the growth of malignant tumors.

Of special importance is the high selectivity of this substance, that is, the fact that it targets only certain objectives (the tumor features). In addition, fruquitinib became the first drug that is able to inhibit all three of the above-mentioned growth factors.

Where is it approved for use?

In the USA, fruquitinib was approved for use in November 2023. And in April 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending authorization to market fruzacl in Europe.

The main benefit is a significant prognosis improvement

The decisions of the US and European drug regulatory authorities are based on promising results from FRESCO-2, a multi-country Phase III study of a total of 691 patients.

The follow-up, which lasted just under one year, showed that the life expectancy of patients receiving fruquintinib significantly exceeded that of the placebo group (by 2.6 months), corresponding to a 34% reduction in mortality.

Indications and route of administration

The new drug will be used as monotherapy to treat adult patients with metastatic colorectal cancer who have previously received standard therapy.

Fruquintinib is particularly suitable for patients who have disease progression or who cannot tolerate treatment with trifluridine/tipiracil or regorafenib.

Fruzaqla is available as hard capsules in 1 mg and 5 mg dosages. The medicine is taken once a day, regardless of meals, with some water.

Side effects and contraindications

At the moment it is known that the drug can cause a number of serious complications. These include, for example, an increase in blood pressure, severe bleeding, infections of the urinary system, throat, lungs, an increase in the level of liver enzymes in the blood.  However, the most common side effects are voice changes and hoarseness, abdominal pain, diarrhea, and asthenia (weakness, increased fatigue, and drowsiness).

In general, during the clinical trials, the majority of patients (80%) were able to tolerate therapy, that is, the side effects were either insignificant, or they could be managed by reducing the dose or interrupting the treatment.

The substance is contraindicated in pregnant women.

Currently it is not known, if it passes into breast milk, so it is not recommended to breastfeed during treatment and for 2 weeks after the last dose.

Since Fruzaqla may affect the effect of other medicines, and the latter, in their turn, may affect the work of Fruzaqla, your doctor should be informed about all the medicines you are taking, including vitamins and herbal supplements.

A glimpse into the future

The results of previous studies suggest that fruquintinib could be a promising new treatment option for patients with advanced metastatic colorectal cancer, especially those who have already failed to respond to other therapies. The new recommendation from the European Medicines Agency therefore offers very good prospects for finding an effective systemic therapy for chemotherapy-resistant cases of colon carcinoma.


1. Sun Q Zhou J Zhang Z et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther. 2014; 15: 1635-1645 

2. Li J Qin S Xu RH 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: 2486-2496




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