Tarlatamab's approval in Europe: When is it coming (and how not to wait)?

Last updated: 17 September 2024

Tarlatamab's approval in Europe: When is it coming (and how not to wait)?

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In May 2024, the FDA granted accelerated approval to Imdelltra (tarlatamab), a first-in-class treatment for extensive-stage small cell lung cancer 1.

This is a pivotal moment for patients with this hard-to-treat type of cancer. However, the hope of a new approved treatment always lives in the shadow of the approval timelines for any patient living outside the US.

Here's what you need to know about tarlatamab's expected approval by the EMA, MHRA, and more. Including ways to safely access the treatment in the meantime.

What is tarlatamab used for?

Imdelltra (tarlatamab) is indicatd for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) when the disease has progressed during or after platinum-based chemotherapy 2.

How does Imdelltra work?

Imdelltra is an innovative bi-specific antibody. It targets both the DLL3 protein on cancer cells and the CD3 antigen on T cells. This action helps the immune system attack and destroy cancer cells in which DLL3 is present.

Amgen reports that the DLL3 protein is found in 85-96% of small cell lung cancer (SCLC) cases but is rarely found in healthy cells.

Interestingly, DLL3 is reportedly expressed in over 76% of castration-resistant neuroendocrine prostate cancer cases 3. This makes tarlatamab potentially interesting as a treatment for this indication, too. A Phase 1 trial investigating this possibility is currently underway 4.

What is tarlatamab's efficacy in clinical trials?

Imdelltra's accelerated FDA approval was based on the results of the Phase 2 DeLLphi-301 clinical trial 5. In this trial, the key reported results were:

  • 40% of patients treated with tarlatamab had a partial or complete response to the treatment;
  • The median progression-free survival was 4.9 months;
  • The median overall survival was 14.3 months;
  • Of the patients who responded to treatment, 58% were still experiencing the response after 6 months, and 55% continued to experience it at data cutoff;
  • The most common adverse events were cytokine release syndrome (CRS), fever, appetite loss, and a metallic taste. CSR was observed mostly at the first and second dose of the medicine, and was generally low-grade 5.

The results from the Phase 1 DeLLpro-300 trial focusing on neuroendocrine prostate cancer are expected after August 2025.

Is tarlatamab FDA approved?

Yes, Imdelltra (tarlatamab) received an accelerated approval by the FDA in May 2024. In order to maintain its approved status, tarlatamab will need to confirm its clinical benefits in additional clinical trials.

When will Imdelltra (tarlatamab) get EMA approval?

As of June 2024, no official marketing authorization application has been submitted to the EMA. However, in January 2024, the EMA granted tarlatamab an orphan medicine designation 6. This means that when an EMA approval application for the medicine is submitted, it may benefit from a shorter approval timeline than the typical 210 days.

Assuming that Imdelltra's marketing authorization application will be submitted before the end of the year, it's technically possible that the medicine will get its EMA approval within 2025.

When will tarlatamab be available in Europe?

If we assume the best-case scenario, in which tarlatamab gets its European approval by mid-2025, that still doesn't mean that it will become available across Europe at the same time. 

Each EU member state has its own local process and timeline for launching newly approved medicines. The EU average for orphan medicines is 636 days, with Germany being the fastest (102 days) and Estonia - the slowest (1,081 days) [7]. 

In other words, even looking at the best-case scenario, the earliest some countries in Europe may make Imdelltra available is in late 2025. Patients in other countries may be facing over 2 years of additional waiting time.

When will tarlatamab be approved in the UK?

Tarlatamab has been included in the FDA's Project Orbis - an initiative for concurrent submission and review of oncological treaments. The UK's MHRA is also part of the project. This being said, the medicine is not yet officially approved in the UK, although the FDA has already given it its green light.

Hopefully, an MHRA approval is coming for tarlatamab before the end of 2024.

When will tarlatamab be available to UK patients?

Let's assume that Imdelltra gets its MHRA approval by the end of 2024. Before it can be included on the NHS and become available to patients in the UK, tarlatamab will need a positive evaluation from NICE.

NICE has already initiated a review of the medicine, with an expected decision date in December 2024. If the outcome is positive, UK patients may be able to start treatment with tarlatamab before mid-2025.

When will Imdelltra be available in other countries?

Tarlatamab is being evaluated for approval in several other countries, including:

  • Canada: Also part of Project Orbis, Health Canada has been reviewing tarlatamab's application for approval since January 2024. Medicine approval processes in Canada can take between 7 months and a year, meaning that the medicine could theoretically get local approval by end of 2024 or early 2025. 
  • Brazil: ANVISA has been included in Project Orbis and a decision may be coming soon. Brazil's medicine approval process typically takes up to 120 days, so an approval within 2024 may still be possible.
  • Israel: Also included in Project Orbis, Israel's Ministry of Health is reviewing Imdelltra for approval. The local process can take up to 270 days, meaning that we're likely looking at late 2024 to early 2025 as a potential approval date. 
  • Japan: In May 2024, Amgen filed an approval application for tarlatamab with Japan's PMDA. The process can take up to a year in Japan, which means that the medicine may get the green light around mid-2025.  

What if the medicine approval process of your country takes a long time, or you're based somewhere where it hasn't even started?

How to get Imdelltra (tarlatamab) before it's approved in your country

Are you a patient with extensive-stage small cell lung cancer? If your doctor is of the opinion that you might benefit from treatment with tarlatamab, you may not need to wait for its local approval. Instead, you could consider buying the medicine immediately via Named Patient Import.

Tarlatamab expanded access (compassionate use)

In most countries, patients are legally allowed to buy and import medicines that could enhance their quality of life or address life-threatening conditions. If you want to access Imdelltra before its approval in your country, this might be an option for you and your doctor.

The regulation making this possible is known as Named Patient Import. There may be variations across countries in terms of the specific administrative requirements. However, in all cases these criteria must be met:

  • The medicine in question has market approval in another country and is not (yet) approved or available in the patient's country;
  • There is no alternative on the local market;
  • The medicine is for personal use;
  • The patient has a prescription from their treating doctor;
  • The doctor takes responsibility for the treatment. This might require different documentation from country to country.

Do you want to use the Named Patient Import regulation to get tarlatamab before its EU approval (or its approval in the UK, Israel, Canada, Japan, or elsewhere)? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with buying Imdelltra immediately. Get in touch with us for more information.