Margetuximab's EMA approval: When is it coming, and how to avoid waiting?

Last updated: 13 March 2024

For patients with metastatic HER2-positive breast cancer, there are several third-line treatments available. These may include Tukysa (tucatinib), Herceptin (trastuzumab) with chemotherapy, Kadcyla (T-DM1), Tyverb (lapatinib), or Margenza (margetuximab). Of all these options, only Margenza (margetuximab) is not yet approved in Europe and the UK.

What if your doctor prescribes margetuximab for breast cancer? Here's everything you need to know about margetuximab's EMA approval and MHRA approval. Including all your options for accessing Margenza (margetuximab) immediately.

What is margetuximab used for?

Margenza (margtuximab) is used in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer. The medicine is a third-line therapy. It's applicable after two or more prior anti-HER2 regimens, of which at least one was for metastatic disease ¹.

Margetuximab is a targeted immunotherapy. It binds to the HER2 receptors on the surface of breast cancer cells and blocks them from receiving growth signals. By doing so, margetuximab can help slow or stop the growth of the tumour. In addition, it also helps immune cells better attack and destroy HER2-positive breast cancer cells ².

How is margetuximab different from trastuzumab?

Both margetuximab and trastuzumab have similar mechanisms of action. However, some clinical studies suggest that margetuximab may have an advantage at reducing the risk of disease progression. One example is the SOPHIA phase 3 clinical trial. Some of the results it showed were:

a 24% relative reduction in the risk of progression in patients treated with margetuximab and chemo vs trastuzumab and chemo;
a median overall survival of 21.6 months for margetuximab patients vs 19.8 months for trastuzumab patients ³.

Margetuximab EMA approval: What's the status?

As of December 2023, Margenza (margetuximab) is not approved by the EMA. There is no active marketing authorization application in review. This means that there are no indications for Margenza (margetuximab) to be approved and available in Europe any time soon.

When will margetuximab be available in the UK?

Margetuximab is not currently approved by the MHRA in the UK. There is no NICE evaluation in progress, either. Unfortunately, this means that also breast cancer patients in the UK won't have access to Margenza in the foreseeable future.

Ways to safely access margetuximab before its EMA approval

Are you a patient with metastatic HER2-positive breast cancer? Waiting to see if and when margetuximab receives EMA approval may not be an option for you. Fortunately, there are safe and quick ways to access Margenza in the meantime.

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

Join a margetuximab clinical trial

To get quick access to margetuximab in Europe or the UK, you can try joining an ongoing clinical trial. Finding one isn't always easy, but it is possible. In order to participate in a clinical trial, you must meet the eligibility criteria. You need to be aware you might be on a placebo in the trial. You will also need your treating doctor's support to be able to participate.

Here are some good places to start looking for ongoing fruquintinib 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 no actively recruiting clinical trials with margetuximab, but this can change quickly, so it's good to keep an eye on the database.
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 margetuximab 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 margetuximab 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 the patient’s 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 margetuximab 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? Our team at Everyone.org can support you with buying margetuximab immediately.

Get in touch to buy Margenza