Dato dxd for breast cancer and lung cancer: When is approval coming?
Last updated: 04 February 2025
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You can legally access new medicines, even if they are not approved in your country.
Learn howAfter launching Enhertu (fam-trastuzumab deruxtecan-nxki) in 2019, Daiichi Sankyo and AstraZeneca are now partnering again in a push for the approval of datopotamab deruxtecan (Dato-DXd). Similarly to Enhertu, dato dxd is initially intended for patients with advanced HER2-low and HER2-negative breast cancer. However, it may have more potential applications than that, for example - in lung cancer.
In January 2025, the FDA approved dato dxd for breast cancer. Its EMA approval is also in sight. Here's what you need to know about approval and availability timelines, for both breast cancer and lung cancer. Including all your options for accessing the treatment in the meantime.
How does Dato-DXd work for breast cancer and lung cancer?
Datopotamab deruxtecan (Dato-DXd) is a specialized cancer treatment known as an antibody-drug conjugate. It targets TROP2, a protein found on many cancer cells. It works by attaching to these cells and delivering a powerful anti-cancer medicine (deruxtecan) directly inside them. This targeted approach allows Dato-DXd to effectively kill cancer cells while causing less harm to healthy cells. This could potentially lead to fewer side effects compared to traditional chemotherapy.
How effective is Dato-DXd in clinical trials?
Based on the clinical trial results available so far, below is what we know about datopotamab deruxtecan's efficacy in treating breast cancer and lung cancer.
Datopotamab deruxtecan in breast cancer: Clinical trial results
Dato dxd's application for FDA and EMA approval has been based on the results of the Phase 3 TROPION-Breast01 trial 1. The trial focused on patients with HR-positive, HER2-low or negative breast cancer, who had previously been treated with endocrine-based therapy and at least one systemic therapy.
Here are the key reportings from the trial:
- Datopotamab deruxtecan reduced the risk of disease progression or death by 37% compared to chemotherapy alone;
- Median progression-free survival was 6.9 months in patients treated with dato dxd, compared to 4.9 months with chemotherapy;
- 36.4% of patients treated with dato dxd responnded partially or completely to the treatment. 22.9% of patients treated only with chemotherapy had this response;
- At the time of interim results reporting, overall survival data had not reached statistical significance. However, the available data numerically favoured datopotamab deruxtecan over chemotherapy 1.
In addition to this trial, these additional trials are also ongoing:
- TROPION-Breast02 and TROPION-Breast03, with a focus on patients with triple-negative breast cancer;
- TROPION-Breast04, focusing on dato dxd in combination with durvalumab as neoadjuvant treatment for early-stage triple negative and HR low, HER2 low or negative breast cancers 2;
- TROPION-Breast05, focusing on patients with advanced or metastatic triple negative breast cancer whose tumors express PD-L1 2.
Datopotamab deruxtecan in NSCLC: Clinical trial results
Dato dxd's applicattion for FDA and EMA approval was supported by the results from the phase 3 TROPION-Lung01 trial. The trial focused on dato dxd versus docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after at least one prior line of therapy 3.
The key reported results were:
- Dato dxd significantly improved progression-free survival;
- 26.4% of patients treated with dato dxd responded partially or completely to the treatment. In comparison, 12.8% of the docetaxel patients had the same response;
- The median overall survival of patients treated with dato-dxd was 12.9 months, compared to 11.8 months for the control group. While the improvement in overall survvival was not statistically significant across the total trial population, there were pronounced benefirs in patients with nonsquamous NSCLC 4.
Datroway (dato-dxd) in EGFR-mutated NSCLC: Clinical trial results
In the TROPION-Lung05 trial, patients with EGFR-mutated NSCLC were treated with dato-dxd, with the following outcomes being reported:
- 43.6% of patients with EGFR mutations had their tumor shrink or disappear;
- 78.8% of patients in the trial either had a stable disease, or had their tumor shrink or disappear;
- The median duration of response was 7 months 8.
Additional ongoing clinical trials focusing on dato dxd in lung cancer include:
- TROPION-Lung02, which studies dato dxd in combination with pembrolizumab in patients with advanced or metastatic NSCLC;
- TROPION-Lung04, which combines dato dxd with immunotherapy (and chemotherapy) in patients with advanced or metastatic non-small cell lung cancer;
- TROPION-Lung05, which focuses on advanced or metastatic NSCLC with genomic alterations;
- TROPION-Lung07, which focuses on datopotamab deruxtecan with pembrolizumab in 1L NSCLC;
- TROPION-Lung08, focusing on dato dxd with pembrolizumab as a first-line treatment for NSCLC.
Is Dato-DXd approved somewhere?
Yes, as of January 2025, dato-dxd is approved by the FDA in the USA for use in patients with previously treated metatatic HR-positive, HER2-negative breast cancer 7.
In the EU, Datroway received a positive opinion from the CHMP, meaning that its EMA approval is a matter of time, expected to become official in by April 2025.
Previously, Dato-dxd was submitted for FDA and EMA approval for use in nonsquamous NSCLC. However, this application has been voluntarily withdrawn by the medicine manufacturer. Instead, a new approval application has been submitted to the FDA for use of Datroway in treating locally advanced or metastatic EGFR-mutated NSCLC 8. No such application has been submitted to the EMA as of February 2025.
When will Dato-DXd get EMA approval?
Datopotamab deruxtecan has been officially under review by the EMA since 29th February 2024. In January 2025, it received a positive CHMP opinion, meaning that its approval in the EU for use in breast cancer treatment is a matter of some additional administartive time. Realistically, Datroway (dato-dxd)'s EMA approval should be a fact by April 2025.
Datroway's EMA approval for lung cancer, however, is likely to take much longer, as no new application has been submitted for the EGFR-mutated NSCLC indication.
When will dato dxd be available in Europe?
Getting EMA approval and becoming available across Europe aren't the same thing, unfortunately. After EMA approval, it takes each member state a different amount of time to negotiate local prices, reimbursements, and launch a new medicine on the local market. Germany's launch process tends to be the fastest, with an average of 100 days for oncological drugs. At the other end of the spectrum is Romania, where it can take up to 964 days on average for a new cancer medicine to become available.
This means that depending on where in Europe you're based, dato dxd could be available to you as early as the second half of 2025, or as late as 2028 5.
When will datopotamab deruxtecan be approved in the UK?
That's more difficult to say. As of February 2025, there is no marketing authorization application submitted to the MHRA for dato dxd. Neither for breast cancer nor for lung cancer.
However, this doesn't have to mean it will take longer for dato dxd to get MHRA approval for breast cancer. According to post-Brexit regulations, the MHRA can approve medicines locally as soon as they get the green light from another trusted regulatory body (such as the EMA or FDA). This is known as the International Reliance Procedure 6. It wouldn't be surprising if the MHRA decides to take this road for approving dato dxd.
When will dato dxd be available in the UK?
If the MHRA approves datopotamab deruxtecan simultaneously with the FDA or EMA, expected by April 2025, the medicine will then require a NICE assessment before becoming available to patients in the UK. NICE will decide whether to make it available on the NHS. If approved, the medicine should be available to UK patients within three months of the decision date.
Assuming a best-case scenario, where the MHRA follows a potential EMA approval in April 2025, and NICE makes a positive decision soon after, dato dxd could be available in the UK by the second half of 2025. Only time will tell if such a timeline is indeed realistic.
How to get dato dxd before it's available in your country
Despite what the timelines above suggest, waiting is not the only option for patients with HER-negative breast cancer or EGFR-mutated NSCLC in Europe, the UK, or anywhere else.
Now that Datroway has FDA approval, you can immediately access the medicine anywhere else by importing it for your personal use. This option is known as Named Patient Import, or expanded access. Here's how it works.
Datopotamab deruxtecan expanded access
Even if a medicine is not yet approved or available in your country, you can legally access it. A regulation known as Named Patient Import allows you to buy and import a medicine, as long as it meets these conditions:
- it is approved somewhere;
- it is not approved or available in your country (yet);
- it has no local alternatives, and
- it is for personal use.
This process requires a prescription from your treating doctor. As in all other cases, the doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.
Do you want to start your treatment with dato dxd as soon as possible, using the Named Patient Import regulation? 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. We can support you with buying dato dxd immediately.
References:
- Datopotamab deruxtecan significantly extended progression-free survival vs. chemotherapy in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial. AstraZeneca, 23 October 2023.
- Press Release - Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes. Daiichi Sankyo, 18 December 2023.
- Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial. AstraZeneca, 27 May 2024.
- Dato-DXd vs Docetaxel in Previously Treated Advanced/Metastatic Non–Small Cell Lung Cancer: Results of the Randomized Phase III Study TROPION-Lung01. OncLive, 31 October 2023.
- EFPIA Patients W.A.I.T. Indicator 2021 Survey. IQVIA, Accessed 10 June 2024.
- Fast-Tracking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure. Inside EU Life Sciences, 11 September 2023.
- Development timeline for Datroway. Drugs.com, Accessed 04 February 2025.
- Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer. AstraZeneca, Accessed 04 February 2025.