Fruquintinib EMA approval: When is it coming and what to do in the meantime?

So far, 2023 has been a good year in the field of colorectal cancer treatment. Especially after more than a decade without new treatment options for patients without a biomarker.  Fruzaqla (fruquintinib) is changing that by gaining approval in the USA as a treatment for advanced colorectal cancer ¹. An oral, chemotherapy-free medicine, Fruzaqla is expected to offer survival benefits for patients despite treatment with prior therapies ⁴.  

However, FDA approval doesn't mean much to patients in Europe, since fruquintinib's EMA approval isn't a fact yet.

Here's everything you need to know about fruquintinib's approval in Europe and the UK. Including all your options for accessing the medicines before it's locally available. 

What is fruquintinib used for?

Fruzaqla (fruquintinib) is indicated for adult patients with metastatic colorectal cancer, who have been treated with chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy (if applicable) ².

Fruquintinib is a selective oral inhibitor. It targets and blocks certain proteins (VEGFR -1, -2, and -3) which play a role in the growth of blood vessels in tumours. By doing this, fruquintinib helps to stop tumours from getting the blood supply they need to grow.

Fruzaqla is made to be very selective, meaning it mainly affects the intended targets and not much else. This allows patients to take a higher dose, and it can be used together with other oncological treatments ³. 

Fruquintinib EMA approval: What's the status?

In June 2023, the EMA accepted a marketing authorization application for Fruzaqla (fruquintinib) ⁵. The application is currently under review, which could take up to 210 days. If the review results in a positive recommendation, fruquintinib's EMA approval should be a fact within 67 days from receiving the CHMP's positive opinion ⁶. 

In other words, the earliest timeline for fruquintinib to be approved in Europe is April 2024. 

When will fruquintinib be available in Europe?

If fruquintinib gets EMA approval in April 2024, that unfortunately doesn't mean it will be immediately available to patients. Before that happens, local health authorities need to have price negotiations with the manufacturer, as well as decide on local health insurance coverage. These processes take a different amount of time in each member state. 

On average, new oncological treatments take 545 days after EMA approval to become available on the EU market. This timeline is dramatically different per country, ranging from 100 days in Germany to 964 days in Romania ⁷.

Essentially, this means that fruquintinib will not be available in the EU until at least the second half of 2024.

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When will fruquintinib be available in the UK?

Fruquintinib is currently not approved by the MHRA in the UK, either. An evaluation by NICE has been initiated. It will determine whether fruquintinib will be available on the NHS. However, there is no timeline provided for the outcome of the evaluation ⁸. 

If the NICE's recommendation is positive, fruquintinib should be available on the NHS within 3 months on average ⁹. That's assuming that the MHRA's approval is a fact in the meantime.

Ways to safely access Fruzaqla (fruquintinib) before its EMA approval

If you're a patient with advanced colorectal cancer, waiting for over a year until fruquintinib becomes available to you, may not be an option. The good news is, you don't have to wait. 

You have two options for accessing Fruzaqla before it's approved in Europe and the UK. One is to join a clinical trial. The other is to buy fruquintinib right away as an Individual Named Patient.

Join a fruquintinib clinical trial

To get quick access to Fruzaqla, you can try joining an ongoing clinical trial. Finding one can be difficult, but it is possible. In order to participate in a clinical trial, you must meet the eligibility criteria. You will also need your treating doctor's support.

Here are some good places to start looking for ongoing fruquintinib clinical trials:

• ClinicalTrials.gov: This is a database with all clinical trials in the USA. However, some of the trials are also open to international participants. At the moment, there are multiple trials involving fruquintinib, which have not started recruiting participants yet and have not defined their locations. These may be worth keeping an eye on.
• EUClinicaltrials.eu: This database contains all clinical trials in the European Union. Currently, it contains limited information on trials launched before 31 January 2022. For those trials, you can refer to the EU Clinical Trials Register.
• myTomorrows: This organization supports patients in finding treatment options in clinical trials.

 Buy fruquintinib as an Individual Named Patient

In most countries, patients are legally allowed to buy and import medicines that could improve their lives or address life-threatening conditions. Especially if these medicines are not approved or available locally yet.

If you want to access fruquintinib before its EMA approval or MHRA approval, this might be an option for you and your doctor.

The regulation that makes this possible is known as the Individual Named Patient Import regulation. Under this regulation, patients can import a medication not yet approved or available in their country if:

• it is approved elsewhere;
  
• it has no local alternatives, and
  
• it is for personal use.

This process requires a prescription from the patient’s treating doctor. The doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Do you want to use the Individual Named Patient Import regulation to get fruquintinib before its approval in Europe or the UK? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with buying fruquintinib immediately.

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References:

1. FDA Approval of Fruquintinib Expands Later-Line Treatment Options in mCRC. OncLive, 17 November 2023.
2. Reference ID: 5275059. Accessdata.fda.gov, Accessed 21 November 2023.
3. New colorectal cancer treatment approved in the U.S. Takeda, 8 November 2023.
4. Mauro, Gina. FDA Approves Fruquintinib for Metastatic Colorectal Cancer. OncLive, 8 November 2023.
5. Medicines for human use under evaluation. European Medicines Agency, Accessed 21 November 2023.
6. Applying for EU marketing authorisation for medicinal products for human use. European Medicines Agency, Accessed 21 November 2023.
7. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 21 November 2023.
8. Project information | Fruquintinib for previously treated metastatic colorectal cancer ID6274 | Guidance. NICE, Accessed 21 November 2023.
9. Ewbank, Leo. Access to new medicines in the English NHS. The King's Fund, 28 October 2020.