What are the new medicines for lung cancer (and how to get them in Poland)?

Lung cancer is the leading cause of death in Poland, leading to about 21,000 deaths annually ¹. Despite recent progress in treatments, many patients still face challenges. Among others, due to delays in access to state-of-the-art medicines.

The good news is that lung cancer patients in Poland can access some of the newest, most advanced medicines in the world. Even if they are not yet approved or available locally. In this article, you’ll discover some of the latest breakthrough treatments for different types of lung cancer and how to get them in Poland.

What are the newest immunotherapies for lung cancer in the world [2025]?

In the past decade, immunotherapy has transformed lung cancer care - particularly for non-small cell lung cancer (NSCLC), though advances have also been made in treating small cell lung cancer (SCLC). These treatments help the immune system recognize and destroy cancer cells, improving survival and quality of life for many patients.

Here are some of the latest approved lung cancer immunotherapies making an impact globally.

#1: Imdelltra (tarlatamab) — for patients who have exhausted other options

Imdelltra (tarlatamab) is an innovative immunotherapy for adults with advanced small cell lung cancer (SCLC) that has worsened despite previous platinum-based chemotherapy ².

Imdelltra is the first of a novel class of medicines called bispecific T-cell engagers. It is a type of targeted immunotherapy designed to direct immune cells to attack cancer more efficiently. The way it achieves that is by interacting with both the CD3 protein on T-cells and DLL3, a protein overexpressed by certain cancer cells, while barely being present in healthy cells ³.

How effective is Imdelltra (tarlatamab) for lung cancer?

Based on the available clinical trial results, this is what we know about its efficacy:

• 40% of patients treated with Imdelltra had their tumor shrink or disappear;
• The median duration of response was 9.7 months;
• For 68% of patients, their response to the therapy lasted at least 6 months ⁴.

Is Imdelltra available in Poland?

As of March 2025, Imdelltra is not yet approved in the EU or available in Poland. It is currently only approved in the USA and, since January 2025, in the United Kingdom ⁵.

However, if your oncologist considers it suitable for your condition, you can get the medicine right away in Poland. We can help you get started below, if you already have a prescription.

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#2: Hetronifly (seribantumab) - a new medicine for small cell lung cancer

Approved in the EU in February 2025, Hetronifly (seribantumab) is indicated as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), alongside carboplatin and etoposide. Hetronifly is currently the only anti-PD-1 monoclonal antibody approved in the EU for the treatment of small cell lung cancer ⁶.

How effective is Hetronifly?

Based on the results of the phase 3 ASTRUM-005 clinical trial, this is what we know about seribantumab's success rate in SCLC:

• The median overall survival was 15.4 months for patients taking Hetronifly, compared to 10.9 months in the placebo group;
• The median progression-free survival was 5.7 months for the Hetronifly group, compared to 4.3 months for the placebo group ⁷.

These results point to the potential importance of seribantumab as a first-line therapy to improve overall survival in patients with small cell lung cancer.

Is Hetronifly available in Poland?

Despite its recent EU approval, Hetronifly is not yet available in Poland. On average, it takes 888 days from EMA approval until an oncological medicine becomes available to Polish patients. While this timeline can vary per medicine, it wouldn't be surprising if Hetronifly only gets to Poland around 2027.

This being said, if you have a doctor's prescription, you may be able to legally access the treatment right away. Get in touch with our expert Medicine Access team for support.

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What are the newest targeted therapies for lung cancer in the world [2025]?

In addition to immunotherapy, new targeted therapies have also been developed in recent years to attack specific genetic mutations responsible for lung cancer. These treatments help provide more personalized and often more effective options for patients.

Here are some of the latest targeted medicines for lung cancer.

#1: Lazcluze/Leclaza (lazertinib) — the new pill for EGFR-positive NSCLC

Lazertinib is a third-generation oral targeted therapy for non-small cell lung cancer (NSCLC) with EGFR mutations. It was first approved in South Korea in 2021, and since then has also gained FDA and EMA approval.

How effective is lazertinib for lung cancer?

Clinical studies show that Lazertinib (Leclaza/Lazcluze), alone and in combination with Rybrevant (amivantamab), offers promising results for EGFR-mutated non-small cell lung cancer (NSCLC):

• As a first-line treatment (LASER301 study):
  • Median progression-free survival (PFS): 20.6 months with Lazertinib vs. 9.7 months with gefitinib.
  • Median duration of response: 19.4 months with Lazertinib vs. 8.3 months with gefitinib.
  • 18-month survival rate: 80% with Lazertinib vs. 72% with gefitinib ⁸.
• In combination with Rybrevant (MARIPOSA trial):
  • Progression-free survival: 23.7 months with Lazertinib + Rybrevant vs. 16.6 months with osimertinib.
  • Median duration of response: 25.8 months with Lazertinib + Rybrevant vs. 16.8 months with osimertinib.
  • Overall survival (OS): Expected to extend survival by more than one year beyond Tagrisso (osimertinib), with the potential to surpass four years, approaching curative outcomes for some patients ⁹.
• As a second-line treatment (for EGFR T970M mutation):
  • Disease control rate: 72.8% of patients had stable disease or tumor shrinkage.
  • Progression-free survival rates: 81.7% at 6 months and 65.1% at 12 months.

These results position Lazertinib — especially when combined with Rybrevant — as a strong alternative to Tagrisso. And, as a potential new standard for EGFR-mutated NSCLC treatment.

Is Lazertinib available in Poland?

EMA approval for Lazertinib is expected any day now. The CHMP recommended granting it marketing authorization in November 2024, and making the approval official takes about two months ¹⁰. However, in Poland, the average wait time for public access after EMA approval is over 800 days.

Fortunately, with a valid prescription, you can access the medicine immediately. Get started by requesting it below.

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#2: Augtyro (repotrectinib)

Approved in the EU in January 2025, Augtyro (repotrectinib) treats ROS1-positive NSCLC, a rare and difficult-to-treat subtype of lung cancer. Augtyro is also approved as a treatment for patients with solid cancers with the NTRK gene mutation. The medicine is especially suited for patients whose cancer has become resistant to earlier NTRK inhibitors ¹¹.

How effective is Augtyro for lung cancer?

Based on the results of the TRIDENT-1 clinical trial, this is what we know about the success rate of repotrectinib:

• 77% of patients previously untreated with an ROS1-inhibitor had their tumor shrink;
• The treatment response lasted for an average of around 34 months;
• 49% of patients who had received one prior ROS1-inhibitor had their tumor shrink. The treatment response lasted for an average of 15 months ¹¹.

Is Augtyro available in Poland?

Augtyro (repotrectinib) has been approved in the EU since January 2025. However, it is not yet available in Poland. It may take from a few months to a couple of years for this to happen.

However, with a doctor's prescription, you can get the medicine for personal use without waiting. Start by placing a request below.

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Always the best and newest drugs for lung cancer

It can take years for new lung cancer treatments to become available in Poland, even after EMA approval. But as a patient, you don’t have to wait. Your doctor can prescribe a medicine even before it's registered locally, and you can get it immediately for personal use, via the Named Patient Import regulation.

If you or a loved one needs help accessing the newest lung cancer treatments in Poland, our team at Everyone.org is ready to assist you at every step.

Referenzen:

1.  Pyenson, Bruce, et al. Cost and Effectiveness of Lung Cancer Screening in Poland: a 15-year projection. Milliman, 8 November 2024.
2. HIGHLIGHTS OF PRESCRIBING INFORMATION. Accessdata.fda.gov, Accessed 4 March 2025.
3. Imdelltra Tarlatamab Commercial Success To Drive DLL3 Targeted Therapy Market. BioSpace, Accessed 04 March 2025. 
4. IMDELLTRA™ (tarlatamab-dlle): DLL3-Targeting BiTE® Therapy for 2L+ ES-SCLC. ImdelltraHCP. Accessed 4 March 2025.
5. Tarlatamab Earns UK Approval for Previously Treated ES-SCLC. OncLive, 6 January 2025.
6. Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)-Media. Henlius.com, 5 February 2025.
7. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. PubMed, 27 September 2022.
8. Lazertinib gegenüber Gefitinib als Erstlinienbehandlung bei Patienten mit EGFR-mutiertem fortgeschrittenem nicht-kleinzelligem Lungenkrebs: Ergebnisse aus LASER301. PubMed, 10. September 2023.
9. South Korea's FDA-approved Leclaza offers breakthrough in lung cancer survival. Chosun.com, 15 January 2025.
10. Lazcluze | European Medicines Agency (EMA). European Medicines Agency, 15 November 2024.
11. Augtyro | European Medicines Agency (EMA). European Medicines Agency, 28 January 2025.