When is toripalimab getting its EMA approval (and how not to wait)

For patients with nasopharyngeal carcinoma (NPC), 2023 ended with some good news. In October, the FDA approved Loqtorzi (toripalimab) as the first immunotherapy for the condition ¹. Toripalimab had already been approved in China (under the name Tuoyi) ².

This is a big milestone, considering that NPC patients are rarely included in clinical trials. For years, they've had to rely on therapies that weren't specifically developed for their condition.

But what if you're an NPC patient outside the USA or China? When will toripalimab be available in Europe or the UK? Here's everything you need to know about MHRA and EMA approval timelines. Including all your options to get the treatment earlier.

What is toripalimab used for?

Loqtorzi (toripalimab) is a prescription medicine that can be used:

• alone to treat adults with nasopharyngeal carcinoma (NPC). More specifically, cases where the disease is inoperable, metastatic, and has progressed after chemotherapy;
• together with cisplatin and gemcitabine as a first-line treatment in adults with metastatic or recurrent locally advanced NPC ³.

The above indications are approved in both the USA and China. In China alone, toripalimab is additionally approved to treat:

• unresectable or metastatic melanoma;
• locally advanced or metastatic urothelial carcinoma. The treatment applies when chemotherapy did not work or the disease progressed after;
• inoperable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). In this case, toripalimab is used in combination with chemotherapy;
• EGFR-negative and ALK-negative, inoperable, locally advanced or metastatic non-squamous non--small cell lung cancer (NSCLC). Also here toripalimab is used in combination with chemotherapy ².

Toripalimab's EMA approval: When is it expected?

Toripalimab's marketing authorization application has been under review by the EMA since December 2022. Typically, application reviews take up to 210 days, excluding any pauses to request additional information from the manufacturer. In toripalimab's case, the review process is taking longer. There is no indication of an expected decision date, but it is possible that toripalimab's EMA approval comes very soon.

Note that the marketing authorization application of toripalimab is only for its NPC indication. The additional indications for which the medicine is approved in China are not currently being considered by the EMA.

When will toripalimab be available in Europe?

Assuming that toripalimab is likely to get its approval any day now, how soon after will it be available to patients in Europe?

As soon as the CHMP gives a positive recommendation on a marketing authorization application, it takes up to 67 days for the EMA approval to become official. From that point on, each EU member state can start its own process for making the medicine locally available. This includes price negotiations, as well as potential cost reimbursement. These processes take a different amount of time per country - from 100 days on average in Germany to over 900 days on average in Romania ⁴.

In other words, some European patients may already have access to toripalimab within 2024. Others are likely to face another couple of years' wait.

When will toripalimab be available in the UK?

Toripalimab's manufacturer, Junshi Biosciences, submitted a marketing authorization application to the MHRA in November 2022 ². As of March 2024, there is no decision made on the application yet. Typically, MHRA approvals take about 210 days, excluding any pauses to ask for additional data. With this in mind, toripalimab's MHRA approval may be just around the corner.

As soon as the MHRA gives its green light, NICE will have to assess toripalimab for potential inclusion on the NHS. This review can take a few months, and, within 3 months of a positive decision, the medicine should be available on the NHS.

With these timelines in mind, it's possible that toripalimab becomes available in the UK within 2024.

How to get toripalimab before its MHRA and EMA approval

If you're an NPC patient in Europe or the UK, waiting for months or a year until Loqtarzi (toripalimab) becomes available to you, may not be an option. The good news is, you don't have to wait.

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

Join a toripalimab clinical trial

To get quick access to Loqtorzi (toripalimab), you can try joining an ongoing clinical trial. Finding one isn't always straightforward, but we'll get you started with some good resources below.

In order to participate in a clinical trial, you must meet the eligibility criteria. You will also need your treating doctor's support. Last but not least, you should be aware you might be assigned to the placebo group in the trial.

Here are some good places to start looking for ongoing toripalimab 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 toripalimab, which are mostly based in China or other Asian countries. However, more recruiting locations may become available, so it's worth keeping an eye on the list.
• 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 toripalimab as an Individual Named Patient

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

If you want to start a treatment with Loqtorzi before its EMA approval 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 the patient’s treating doctor. The doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Buy Loqtorzi

Do you want to use the Named Patient Import regulation to get toripalimab 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 at Everyone.org and we will support you with buying toripalimab immediately.

References:

1. FDA Approves Toripalimab for Advanced Nasopharyngeal Cancer. National Cancer Institute, 3 January 2024.
2. Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab. BioSpace, 12 July 2023.
3. Reference ID: 5268318. Accessdata.fda.gov, Accessed 12 March 2024.
4. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 12 March 2024.