After zolbetuximab's EU approval: When will the medicine be available to patients?

Vyloy (zolbetuximab) is the first targeted therapy approved by FDA and EMA for patients with HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction cancer. This marks a significant milestone in the treatment of a type of cancer that tends to be diagnosed in advanced stages and has a 5-year survival rate of 6% ².

However, as is often the case with medicine access, approval is not the same as availability. Now that zolbetuximab is approved in Europe, when will patients across the EU actually be able to start treatment with the medicine?

Here's what you need to know.

What is zolbetuximab used for?

Vyloy (zolbetuximab) is intended for the first-line treatment of adults with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer whose tumors are claudin (CLDN) 18.2 positive ¹. Zolbetuximab is indicated for use together with fluoropyrimidine- and platinum-containing chemotherapy.

According to some data, about 50% of gastric cancers are HER2-negative ⁴. Among them, a positive CLDN 18.2 expression is found in about 49% of cases ³. This means that zolbetuximab could be applicable in a considerable subset of gastric and GEJ cancer patients.

How does zolbetuximab work?

Zolbetuximab is a monoclonal antibody designed to target the protein CLDN 18.2. This protein helps keep stomach lining cells tightly connected, but when these cells become cancerous, CLDN18.2 becomes exposed. Zolbetuximab binds to the cancer cells, enabling the immune system to recognize and attack them. This helps to slow the progression of the disease ⁵.

What are zolbetuximab's results in clinical trials?

Zolbetuximab's FDA and EMA approvals were supported by the reported results of the Phase 3 SPOTLIGHT and GLOW trials. Some of the key findings were:

SPOTLIGHT trial results

In this clinical trial, zolbetuximab was used in combination with 5-fluorouracil, leucovorin, and oxaliplatin. This medicine combination was tested against placebo, with these reported outcomes:

• Median progression-free survival of 10.61 months (vs 8.67 months in the placebo group);
• Zolbetuximab plus 5-fluorouracil, leucovorin, and oxaliplatin reduced the risk of progression or death by 25% compared to placebo;
• Median overall survival of 18.23 months (vs 15.54 months in the placebo group) ⁶.

GLOW trial results

In this trial zolbetuximab was used with a combination of chemotherapy inclydign capecitabine and oxaliplatin (CAPOX) against placebo plus CAPOX. Here are some of the key results:

• Median progression-free survival was 8.21 months (vs 6.8 months for placebo);
• The 12-month progression-free survival rate was estimated as 35% (vs 19% for placebo);
• The 24-month progression-free survival rate was estimated as 14% (vs 7% for placebo);
• Median overall survival was 14.4 months (vs 12.16 months for placebo) ⁷.

These clinical trial results suggest that Vyloy (zolbetuximab), when used along with chemotherapy, may have some benefits for patients in terms of progression-free and overall survival.

Has zolbetuximab been approved in Europe?

Yes, since September 2024, zolbetuximab has EMA approval. However, this unfortunately doesn't mean that the medicine is already available in Europe. Depending on where you're based in the EU, you may need to wait a little longer until Vyloy is locally available.

When will zolbetuximab be available across the EU?

Before a newly EMA-approved medicine like zolbetuximab reaches patients across the EU, several steps need to be completed.

Each member state needs to go through its own process of local price negotiations, reimbursement decisions, and, eventually, market launch. As you can probably guess, some countries are faster than others in doing this.

The average time for an oncological medicine to become available in the EU following EMA approval is 545 days. Germany leads the way with an impressive average launch time of only 100 days, while Romania typically requires about 964 days before patients can access a newly approved oncological therapy ⁹.

As a patient in the EU, this means that you could get zolbetuximab either already in early 2025 or in up to 3 years, depending on your location.

Is zolbetuximab approved in the UK?

After Brexit, medicine approval decisions in the UK are no longer bound to EMA timelines. In the case of Vyloy (zolbetuximab), this has been a positive change, as the medicine was approved by the MHRA already in August 2024 (even before its EMA approval) ⁸.

This being said, zolbetuximab is not available on the NHS just yet. It's awaiting the NICE's decision on the topic. While an evaluation is underway, there is no target decision date, so it's difficult to provide a timeline for Vyloy to be offered on the NHS ¹⁰.

How to get zolbetuximab before it's available in your country?

While Vyloy may take some time to become available to all patients in the EU, that doesn't mean that you have to wait. There is another safe, legal, and quick way to access the medicine before it's available in your country.

Buy zolbetuximab as a Named Patient

When a medicine is not yet approved in your country, or is approved but not yet available, you have the right to buy and import it from another country, for your personal use. The regulation allowing this is known as Named Patient Import.

The regulation applies when a medicine:

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

This process requires a prescription from your treating doctor. Other documentation requirements may apply, depending on your country.

Do you want to use the Named Patient Import regulation to get zolbetuximab before it's available in Europe (or any other country)? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Share it with our team at Everyone.org, so we can support you with buying Vyloy immediately.