Is Elahere approved in Europe (and what to do until it is)?

Last updated: 23 January 2024

In late 2022, the FDA granted accelerated approval to Elahere (mirvetuximabb soravtansine-gynx) as a treatment for adults with FRα-positive platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer ¹. The FDA is currently reviewing the outcome of the confirmatory MIRASOL trial, with an expectation to convert Elahere's accelerated approval to a full approval in April 2024 ².

While this is positive news for patients in the USA, what does it mean for those based in Europe and the UK? Here's everything you need to know about Elahere's approval in Europe and the UK. Including safe ways to access the medicine quickly.

What is Elahere?

Elahere is indicated for the treatment of FR-alfa positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

As a combination of an antibody and an active substance (DM4), Elahere targets the FRα protein in cells and then releases DM4 inside them. DM4 disrupts the cell's microtube network, causing it to stop dividing and eventually die ³.

Based on clinical trial results reported so far, Elahere may reduce the risk of disease progression or death by 35% compared to chemotherapy. It also was reported to perform better than chemotherapy in median overall survival (16.46 months for Elahere patients vs 12.75 months for chemotherapy patients) ².

In the future, Elahere's role in cancer treatment may be even broader than its current indications. That remains to be seen as the PICCOLO and GLORIOSA trials proceed. They are testing Elahere as a third-line monotherapy in ovarian cancer, and as maintenance therapy in combination with Avastin ⁴.

Is Elahere (mirvetuximab soravtansine) approved in Europe?

As of January 2024, Elahere (mirvetuximab soravtansine) has not been approved in Europe. However, its Marketing Authorization Application is under review by the EMA.

Typically, application reviews can take up to 210 days. This timeline may be extended if the EMA requests additional information from Elahere's manufacturer. Assuming the best case scenario, Elahere should receive EMA approval by the end of 2024.

Unfortunately, that won't make it immediately available on the market. Each EU member state will then follow their own procedure to negotiate prices, local insurance coverage and launch timelines. How long these processes take varies greatly across countries - from an average of 133 days in Germany to 899 days in Romania ⁵.

With this in mind, the best case scenario is for Elahere to be availabile in (some) EU coutries in early 2025.

Is Elahere approved in the UK?

As of January 2024, not yet. There is no current indication of a marketing authorization application submitted for Elahere in the UK, and no NICE review has been initiated to consider Elahere for potential future inclusion on the NHS.

With this in mind, it doesn't seem that Elahere will be available to ovarian cancer patients in the UK in the foreseeable future.

How to get Elahere before its EMA or MHRA approval

Do approval timelines in the EU and UK mean that patients have to wait for years to get treatment? Fortunately, no. There are two ways to access Elahere in the EU and the UK before it's locally available.

One option is to find and join a clinical trial involving Elahere. Another option is to buy Elahere immediately as an Individual Named Patient.

Here's what either of these options means.

Join an Elahere clinical trial

This can require some time and effort, as clinical trials in your location may not always be straightforward to find. There are also additional considerations - e.g. you would have to meet the trial's eligibility criteria, and accept the risk that you may be assigned to the control group. However, with your treating doctor's support and the resources below, you may be able to identify a clinical trial that works for you.

Here are some places to start:

ClinicalTrials.gov: This is a database with all clinical trials in the USA. However, some of the trials are also open to international participants. Examples are NCT05456685 and NCT04274426, which accept participants in Spain, Germany, and the UK, among others.
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 Elahere as an Individual Named Patient

In most countries, patients have the legal right to purchase and import medicines that can enhance their well-being or treat severe medical conditions. Particularly if these medicines are not approved or available in the patient's country yet.

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

The regulation that makes this possible is known as the Individual Named Patient Import regulation. It enables patients to import a medicine 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 will require a prescription from your treating doctor. The doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Do you want to use the Individual Named Patient Import regulation to buy Elahere before its approval in Europe or the UK? Start by consulting your treating doctor and getting a suitable prescription.

Already have a prescription? Get in touch with our team at Everyone.org. We can support you with buying Elahere immediately.

How much does Elahere cost?

When it comes to prices for medicines that are not yet approved or available in your country, you should take these as indicative only. The final price may vary depending on your location, or the supplier.

As an indication, a single-dose vial of 100 mg/20 mL Elahere costs approximately EUR 11,343. Typically, you would need one of these vials every 3 weeks, unless otherwise prescribed by your doctor.