Repotrectinib in Europe: When is the novel ROS1-positive lung cancer treatment coming?

The last few years have seen an important shift in non-small cell lung cancer treatment approaches. It's a shift towards targeted therapies for specific tumour cell mutations such as KRAS, EGFR, RET, or ALK. The ESMO Congress 2023 suggested that using mutation-targeted treatment can reduce the need for chemotherapy in some patients ¹.

After Lumakras and Enhertu, the FDA has now also given its green light to Augtyro (repotrectinib) for lung cancer which is ROS1-positive ².

Are you an NSCLC patient outside of the USA? You're probably wondering when this novel ROS1-positive NSCLC treatment will be available to you.

Here's everything you need to know about repotrectinib's approval in Europe and the UK. Including all your fast and safe options for accessing the medicine immediately.

What is the use of repotrectinib in lung cancer?

Repotrectinib is designed to treat a specific subset of NSCLC patients - those with ROS1-positive tumours. About 2.4% of all NSCLC patients have the ROS1 fusion gene and fall within this group ³.

In ROS1-positive lung cancers, fusion proteins that include ROS1 domains can cause cells (including tumour cells) to grow uncontrollably. Repotrectinib targets the specific proteins ROS1, TRKA, TRKB, and TRKC, and blocks their activity. By doing so, it helps limit excessive tumour growth ⁴.

Repotrectinib minimises interactions that could cause treatment resistance in ROS1-positive NSCLC patients ⁵.

How effective is repotrectinib for lung cancer?

In the TRIDENT-1 clinical trial, patients who had not been treated with a tyrosine kinase inhibitor (TKI) therapy reported these outcomes:

• 79% of patients treated with Augtyro (repotrectinib) saw their tumours decrease or disappear;
  
  
• The median duration of response was 34.1 months ⁵.
  
  

For patients who had undergone previous TKI therapy, the outcomes were:

• 38% of those treated with repotrectinib saw their tumours shrink or disappear;
  
  
• The median duration of response was 14.8 months ⁵.
  
  

The safety and efficacy of repotrectinib in paediatric patients is currently also being studied ⁶.

Repotrectinib EMA approval: What's the status?

As of November 2023, repotrectinib has no EMA approval. There is also no marketing authorization application under review. The EMA, however, is looking at the possibility to allow paediatric use of repotrectinib. Specifically in patients with previously treated metastatic solid tumours with ALK/ROS1/NTRK1-3 alterations ⁷.

The results of this investigation are expected in December 2023. It is unclear whether they will also address the use of repotrectinib in adults with ROS1-positive NSCLC.

With this in mind, it's difficult to say when repotrectinib will be available to lung cancer patients in Europe.

When will repotrectinib be available in the UK?

Similarly to the status of repotrectinib's EMA approval, the medicine's MHRA approval is not a fact yet. There is no timeline provided for either the MHRA's or the NICE's review of repotrectinib ⁹.

Whether repotrectinib will be available on the NHS depends on the NICE's recommendation. And NICE can only provide one if the medicine is approved by the MHRA. Unfortunately, this is all we currently know about repotrectininb's availability in the UK. It seems that it will be at least a few months before ROS1-positive NSCLC patients in the UK can access Augtyro (repotrectinib).

Ways to safely access repotrectinib before its approval in Europe and the UK

Are you a non-US patient with metastatic NSCLC? Luckily, that doesn't mean you have to wait for repotrectinib's EMA or MHRA approval.

You can try to access repotrectinib via a clinical trial. Or, you can buy repotrectinib immediately as an Individual Named Patient. In both cases, you would of course need to have your treating doctor's support.

Join a repotrectinib clinical trial

To get quick access to Augtyro (repotrectinib), you can try joining an ongoing clinical trial. It's not always easy to find one, but it is possible. In order to participate in a clinical trial, you must meet the eligibility criteria, and you will need your treating doctor's support.

Here are some good places to start looking for ongoing repotrectinib 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 many trials involving repotrectinib. Some are recruiting international participants, also in Europe. These may be worth keeping an eye on.
• 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 organisation can support you in finding treatment options in clinical trials.
  

Buy repotrectinib as an Individual Named Patient

Patients in most countries have the right to buy and import medicines that can improve their health or treat life-threatening conditions. Especially if these medicines are not available locally (yet).

If you are considering accessing repotrectinib before its approval by the EMA or MHRA, this could be a good option for you and your doctor.

The regulation that enables this is called the Individual Named Patient Import regulation. Patients are allowed to import a medication that has not been approved or is not available in their country if:

• it is approved elsewhere;
  
  

• it has no local alternatives, and
  
  
• it is for personal use.
  
  

To access repotrectinib as an Individual Named Patient, you will need a prescription from your treating doctor. The doctor assumes responsibility for the treatment. Some additional documentation requirements may apply, depending on your country.

Do you want to use the Individual Named Patient Import regulation to get repotrectinib before its EMA or MHRA approval? And do you already have a prescription? Get in touch with our team at Everyone.org, who can support you with buying repotrectinib immediately.

Get in touch about buying repotrectinib

References:

1. Lung Cancer Treatment Research Enters a New Era. European Society for Medical Oncology, 17 October 2023.
2. FDA approves repotrectinib for ROS1-positive non-small cell lung cancer. FDA, 15 November 2023.
3. Zhu, Qingqing, et al. Clinicopathologic characteristics of patients with ROS1 fusion gene in non-small cell lung cancer: a meta-analysis. Translational Lung Cancer Research, Accessed 6 December 2023.
4. Reference ID: 5277680. Accessdata.fda.gov, Accessed 6 December 2023.
5. U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC). Bristol Myers Squibb - News, 15 November 2023.
6. A Phase I/II Study of Repotrectinib in Children and Young Adults with Advanced or Metastatic Cancers Containing ALK, ROS1, or NTRK1-3 Alterations. Memorial Sloan Kettering Cancer Center, Accessed 6 December 2023.
7. European Medicines Agency decision P/0542/2021. European Medicines Agency, Accessed 6 December 2023.
8. Repotrectinib for treating ROS1-positive advanced non-small-cell lung cancer TS ID 11851. NICE, Accessed 6 December 2023.