Tazemetostat's EMA approval: What if waiting is no option?

In 2020, the FDA approved Tazverik (tazemetostat) for the treatment of epithelioid sarcoma and relapsed/refractory follicular lymphoma ¹. This was a positive step forward, especially for epithelioid sarcoma patients, for whom this was the first approved treatment that is specific to their condition. 

Fast forward to the present day and tazemetostat is still only approved in the USA. What does this mean for patients in Europe and the UK? Find out the latest about its EU approval timeline, and all your options to access the medicine earlier. 

What is tazemetostat used for?

Tazverik (tazemetostat) is a prescription medicine for the treatment of:

• metastatic and locally advanced epithelioid sarcoma ineligible for surgery (in patients aged 16 and up);
• relapsed or refractory follicular lymphoma with an EZH2 mutation, after at least two prior rounds of systemic treatment (in adults patients);
• relapsed or refractory follicular lymphoma, where no satisfactory alternative treatments are available (in adult patients) ².

Tazemetostat works by blocking a protein called EZH2. In some people with follicular lymphoma and epithelioid sarcoma, EZH2 is changed in a way that makes B cells grow abnormally. By stopping this altered EZH2 protein, tazemetostat can kill cancer cells and prevent the cancer from spreading.

Additionally, tazemetostat is currently being studied as a potential treatment for other conditions,  including advanced solid tumors (with or without the ARID1 gene mutation), peripheral nerve sheath tumors, diabetes, and more. The results of ongoing (pre-)clinical trials will shed more light on the potential broader role of tazemetostat within and beyond cancer treatment.

Tazemetostat's EMA approval: What's the status?

Unfortunately, as of February 2024, there is no open application for the marketing authorization of tazemetostat within the EU. However, the medicine has had an orphan drug status in the EU since 2018. This means that if an authorization application is submitted, it may be eligible for faster review or for conditional marketing authorization. 

At this moment it's difficult to say when tazemetostat will be available in Europe, but it seems unlikely to be very soon.

When will tazemetostat be available in the UK?

There is no indication of an active MHRA approval application for tazemetostat. Unfortunately, this means that also in the UK, the medicine is unlikely to be available soon. Especially since it would require both the MHRA's approval and a completed NICE assessment before it can be put on the NHS and made available on the UK market. 

Ways to safely access tazemetostat before its EMA and MHRA approval

If you're a patient outside the USA, waiting for an unspecified amount of time until tazemetostat becomes available to you, may not be an option. The good news is, you don't have to wait.

There are two options for accessing Tazverik (tazemetostat) before it's approved in Europe and the UK. One is to join a clinical trial. The other is to buy tazemetostat right away as an Individual Named Patient.

Join a tazemetostat clinical trial

To get quick access to the medicine, you can try joining an ongoing clinical trial. Finding one can be difficult, but with the right resources it can be done. In order to participate in a clinical trial, you must meet the eligibility criteria and have your treating doctor's support. It's also good to be aware that a trial doesn't guarantee you will be assigned to the group that gets the medicine.

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

• ClinicalTrials.gov: 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 the medicine, which are open to international participants.
• 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 and FindMeCure: These organizations support patients in finding treatment options in clinical trials.

Buy tazemetostat as a Named Patient

Patients in many countries have the legal right to purchase and import medications that can improve their health or treat life-threatening conditions, especially if these medications are not yet approved or accessible locally.

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

The regulation that makes this possible is known as the 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 your treating doctor, who also assumes responsibility for the treatment. 

Do you want to use the Named Patient Import regulation to get Tazverik (tazemetostat) 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? Share it with our team and let us support you with buying tazemetostat immediately.

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References:

1. Stewart, Judith. Tazverik (tazemetostat) FDA Approval History. Drugs.com, Accessed 5 March 2024.
2. Reference ID: 4627347. Accessdata.fda.gov, Accessed 5 March 2024.