Zynyz's EMA approval: When will the treatment be available (and how not to wait)

Last updated: 05 March 2024

Merkel cell carcinoma (MCC) is a rare condition. In Europe, its incidence is relatively low, at 0.13 per 100,000, while in the USA, it's higher at 0.79 per 100,000. Australia has the highest frequency with 1.6 per 100,000 ¹.

Despite advancements in understanding and treating MCC, survival rates remain low (0-18% 5-year overall survival), especially for advanced cases ¹. The FDA's accelerated approval of Zynyz (retifanlimab-dlwr) in 2023 brought a glimpse of hope for Merkel cell carcinoma patients worldwide.

A year later, where else is Zynyz approved, and when can patients in Europe and the UK expect to have access to the treatment? Here's everything you need to know.

What is Zynyz (retifanlimab-dlwr) for?

Zynyz is a prescription medicine for adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), which is not a candidate for surgical removal or radiation therapy. Zynyz is used alone, as a first-line treatment ².

What is the success rate of Zynyz?

Based on the POD1UM-201 clinical trial results, here's what we know about Zynyz's success rate in MCC:

34% of patients treated with Zynyz had their tumors shrink in size;
18% of patients treated with Zynyz had their tumors fully disappear;
76% of patients who responded to treatment experienced this response for 6 months or longer; 62% experienced it for 12 months or longer ³.

Zynyz EMA approval: What's the status?

In February 2024, the CHMP made a positive recommendation for the marketing authorization of Zynyz in Europe ⁴. It typically takes up to 67 days for the recommendation to become an official EMA approval. This means that by May 2024, Zynyz should be fully approved in Europe.

When will Zynyz be available in Europe?

Unfortunately, Zynyz's EMA approval won't yet mean it will be immediately available on the EU market. When this happens depends on each member state's procedure, and it can take from 100 days on average in Germany to 964 days on average in Romania ⁵.

Therefore, Zynyz may be available in some European countries by the end of 2024, but other countries may be facing another couple of years' wait before they can get the treatment.

Does Zynyz have UK approval?

Not as of March 2024, and there is no active application for the MHRA approval of Zynyz. If an application were to be submitted now, it would take up to 210 days for the MHRA to make a decision. Afterwards, NICE would need to review Zynyz for potential inclusion on the NHS. If the review has a positive outcome, within 3 months after that Zynyz would be available on the UK market.

Unfortunately, with the timeline above and with no active UK approval application for Zynyz, it doesn't seem likely that the medicine will be available to Merkel cell carcinoma patients in the UK any time soon.

How to safely get Zynyz before it's available in your country

Waiting for an unspecified amount of time isn't a great prospect when you're in need of treatment right now. Fortunately, if your doctor believes that Zynyz (retifanlimab-dlwr) is a suitable treatment for you, you don't have to wait.

You have two main options to get Zynyz before it's available in Europe or the UK - you can join a clinical trial, or you can buy Zynyz as an Individual Named Patient.

Here's how each of these options works.

Join a Zynyz clinical trial

If you want quick access to Zynyz in Europe or the UK, consider joining a clinical trial. It may not be easy to find one, but it is possible. Meeting the eligibility criteria is necessary to participate. Keep in mind that you may receive a placebo during the trial. Your treating doctor's support is required to participate.

Here are some good places to start looking for ongoing Zynyz 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 several trials recruiting for international patients - including trials in France, The Netherlands, and Italy.
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 Zynyz 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 retifanlimab-dlwr before it's available in Europe and the UK, this is your quickest option.

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 the patient’s treating doctor, who assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Do you want to use the Named Patient Import regulation to buy Zynyz before it's available 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 at Everyone.org and we'll support you with buying Zynyz immediately.