Tivdak's EMA approval: When is it coming (and what to do if you can't wait)

Since 2021, Tivdak (tisotumab vedotin-tftv) has been approved in the USA ¹. For patients with recurrent or metastatic cervical cancer, this has meant one more option available for a condition with limited treatment options.

While Tivdak's accelerated FDA approval was good news, patients based in Europe and the UK are still waiting for the medicine to become available locally. 

Here's everything you need to know about Tivdak's MHRA and EMA approval timelines. Including all your safe and legal options for getting the medicine earlier.

What is Tivdak used for?

Tivdak (tisotumab vedotin-tftv) is a second-line treatment for adult patients with recurrent or metastatic cervical cancer ¹. 

The medicine is an antibody-drug conjugate. It contains both an antibody and a chemotherapy component. Tivdak works by first binding with a specific protein called Tissue Factor on the outer surface of some tumor cells. After that, Tivdak enters the tumor cell and releases its chemotherapy component to kill the cell from the inside.

Tissue Factor is also present on some non-tumorous cells. That's why it's possible that Tivdak also harms normal cells, which may lead to side effects ².

What is Tivdak's success rate?

Tivdak's FDA approval was based on the innovaTV 204 trial. Below are some highlights from the reported results, which can illustrate Tivdak's success rate in cervical cancer.

What were the results of the Tivdak trial?

• 24% of patients treated with Tivdak saw their tumours shrink or disappear. Of the patients who responded to the treatment, about 30% had no detectable tumors, and about 70% had a tumor size reduction.
• The median response duration was 8.3 months ².

What is the survival rate with tisotumab vedotin?

According to the results from the Phase 3 innovaTV 301 trial, Tivdak showed a 30% reduction in the risk of death in cervical cancer patients compared to chemotherapy ³. More specific data reported from the trial include:

• The median overall survival was 11.5 months with Tivdak, compared to 9.5 months with chemotherapy;
• The 12-month survival rates with tisotumab vedotin were 48.7%, compared to 35.3% with chemotherapy;
• The median progression-free survival was 4.2 months with Tivdak and 2.9 months with chemotherapy ⁴.

On the basis of these results, the lead study author Ignace Vergote, MD, PhD, expressed an expectation that Tivdak could become a new standard of care for cervical cancer patients who have progressed after first-line therapy ⁴.

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

As of March 2024, tisotumab vedotin is not yet approved by the EMA. However, its marketing authorization application was accepted by the EMA in February 2024, and is currently in review ⁵. 

When will tisotumab vedotin be available in Europe?

Typically, marketing authorization applications are reviewed within 210 days from submission. Since Tivdak's EMA approval application was accepted in February 2024, it's possible that the application gets a decision by the end of the year or in early 2025. 

Assuming a positive recommendation by the CHMP, Tivdak's EMA approval should become official within 67 days after. 

However, approval isn't the same as availability. Even if Tivdak gets the EMA's green light, it will take some time before each EU member state makes the medicine locally available. Germany is usually the fastest, bringing new oncological treatments to the market within an average of 100 days. At the other end of the spectrum is Romania, where it can take an average of 964 days for a newly approved medicine to become available ⁶.

With this in mind, we can expect that if Tivdak gets its EMA approval, it will be available in some European markets within 2025. Other EU countries may need to wait an additional couple of years.

When will Tivdak be available in the UK?

As of March 2024, Tivdak(tisotumab vedotin-tftv) is not yet approved by the MHRA. However, based on information from the NICE website, a regulatory appraisal may be expected to begin around July 2024 ⁷. If that is the case, it should take about 210 days for the MHRA to make a decision. This takes us to mid-2025.

Assuming that Tivdak gets the MHRA's approval, NICE will also need to complete its own assessment of the medicine for potential inclusion on the NHS. If that is positive, Tivdak should be made available to UK patients within 3 months after the NICE gives its green light. 

Given this timeline, the first possibility for UK patients to access Tivdak would be somewhere in the second half of 2025. 

How to safely get Tivdak before its MHRA or EMA approval

Are you a patient with metastatic cervical cancer? If you're based in the EU or the UK, you may be underwhelmed by the prospect of waiting for years before you can start a treatment with Tivdak.  Fortunately, there are safe and quick ways to get tisotumab vedotin before it's available in your country.

One of your options is to try and join a clinical trial involving Tivdak. The other option is to buy Tivdak right away as an Individual Named Patient.

Join a tisotumab vedotin clinical trial

To get quick access to Tivdak in Europe or the UK, you can try joining an ongoing clinical trial. Finding one can be challenging, but with your doctor's support, it can be done. In order to participate in a clinical trial, you must meet the eligibility criteria. You should also be aware you might be assigned to the placebo group in the trial. 

Here are some good places to start looking for ongoing tisotumab vedotin 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 - this one, for example.
• 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 Tivdak as an Individual Named Patient

Even if a medicine is not yet approved or available in your country, you are legally allowed to buy and import it. Especially if it could improve your life or address a life-threatening condition.

If you want to access tisotumab vedotin before its EMA approval or MHRA approval, this is your quickest option.

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 your treating doctor. The doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Buy Tivdak

Do you want to use the Named Patient Import regulation to buy Tivdak 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? Send it to our team at Everyone.org and we will support you with buying tisotumab vedotin immediately.

 References:

1. FDA grants accelerated approval to tisotumab vedotin-tftv. FDA, 20 September 2021.
2. About Tivdak® (tisotumab vedotin-tftv). Tivdak, Accessed 12 March 2024.
3. TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial – Zai Lab Limited. Zai Lab Limited, 22 October 2023.
4. Tisotumab Vedotin Improves Survival in Recurrent/Metastatic Cervical Cancer. OncLive, 22 October 2023.
5. Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer. Genmab, 2 February 2024.
6. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 12 March 2024.
7. Project information | Tisotumab vedotin for treating recurrent or metastatic cervical cancer after systemic therapy [ID3753] | Guidance. NICE, Accessed 12 March 2024.