What are the newest treatments for cervical cancer (and how to get them in Poland)?

Cervical cancer continues to pose a significant health challenge globally. Poland in particular doesn't have the highest incidence rate of cervical cancer (ranking 18.9 out of 27 countries). However, it does have a cervical cancer mortality rate that is twice the European average, with only 55% of women surviving 5 years after diagnosis ¹.

These numbers highlight the importance not only of prevention and screening, but also of making the newest treatments for cervical cancer available in Poland faster than they currently are.

The good news is that there are new treatments getting approval around the world. And there are ways to get them in Poland before they are locally approved or available.

Here's what you need to know.

What are the newest immunotherapies for cervical cancer?

Immunotherapy is one of the latest developments in cancer treatment. While it is not yet replacing traditional treatments such as surgery or chemotherapy, immunotherapy can be a crucial element of cervical cancer treatment. Especially in cases of advanced or metastatic disease, which in Poland are often seen, due to late diagnosis ².

According to Dr. Radosław Mądry from the University Clinical Hospital and Medical University in Poznan, there has been no significant improvement in the way cervical cancer patients have been treated in Poland for the last 10 years ³. Luckily, there are more treatment options being approved, and more of them are available in Poland.

Here are some recent approvals to consider with your doctor:

#1: Tivdak (tisotumab vedotin): the newest medicine for cervical cancer

An antibody-drug conjugate targeting tissue factor, Tivdak was first approved in the USA in 2021. In January 2025, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending Tivdak's marketing authorization. Formal EMA approval is anticipated by March 2025.

How effective is Tivdak for cervical cancer?

Tivdak has shown promising results in clinical trials. The phase 3 innovaTV 301 trial demonstrated that Tivdak significantly improved overall survival in patients with recurrent or metastatic cervical cancer. Additional key findings were:

• 18% of patients treated with Tivdak responded to the treatment, compared to 5% who were treated with chemotherapy;
• The median overall survival of patients on Tivdak was 11.5 months, compared to 9.5 months for those receiving chemotherapy ⁴.

Is Tivdak available in Poland?

As of February 2025, not yet. Tivdak is expected to get its official EMA approval in March 2025. After that , its availability in Poland will depend on national authorization and inclusion in reimbursement schemes, processes that take 888 days on average ⁵.

In other words, Tivdak is unlikely to be available in Poland before 2027. In the meantime, Polish patients can access Tivdak right away, via the Named Patient Import regulation. It allows for the legal importation of medicines approved elsewhere but not yet available locally.

This pathway involves out-of-pocket expenses, but provides a viable solution for accessing innovative treatments without a delay, until national approval and reimbursement are secured.

To get immediate access to Tivdak in Poland, request the medicine below.

#2: Keytruda (pembrolizumab)

This immune checkpoint inhibitor targets the PD-1 pathway, enhancing the body's immune response against cancer cells. Keytruda is approved in the USA and the EU in combination with chemotherapy (with or without bevacizumab) for patients with persistent, recurrent, or metastatic cervical cancer with a PD-L1 expression. In January 2024, the FDA expanded its approval to include use with chemoradiotherapy for patients with FIGO 2014 Stage III-IVA cervical cancer.

How effective is Keytruda for cervical cancer?

Keytruda (pembrolizumab) has demonstrated significant efficacy in treating cervical cancer. Some of the key reported findings from clinical trials include:

• In people with FIGO 2014 Stage 3 to 4A cervical cancer, Keytruda combined with chemotherapy and radiation therapy reduced the risk of cancer progression by 41%, compared to chemotherapy and radiation therapy alone ⁸.
• In patients with PD-L1 positive advanced cervical cancer, Keytruda with chemotherapy with bevacizumab led to the tumor shrinking or disappearing in 68% of cases, compared to 50% for patients on combination therapy alone. For 42.5% of patients taking Keytruda, the cancer did not progress, compared to 28% of patients on combination therapy alone ⁷.
• In patients with advanced metastatic cervical cancer, Keytruda alone led to tumors shrinking or disappearing in 14.3% of cases. The length of time patients responded to Keytruda ranged from 4.1 to 18.6+ months ⁶.

Is pembrolizumab available in Poland?

Yes. Keytruda (pembrolizumab) has been approved in the EU since 2015 and has been available under the reimbursement scheme of the National Health Fund in Poland since 2024 ². However, while this is the situation on paper, there have been concerns about the actual availability of Keytruda to patients across the country ¹¹. If you're struggling to access Keytruda locally, remember that you can always access it for personal use via the Named Patient Import regulation. For more information, get in touch with our expert team.

#3: Libtayo (cemiplimab)

Libtayo (cemiplimab) is an immune checkpoint inhibitor. It targets the PD-1 receptor, enhancing the immune system’s ability to recognize and attack cancer cells.

Initially approved for non-small cell lung cancer and cutaneous squamous cell carcinoma, Libtayo has also been found effective in treating recurrent or metastatic cervical cancer. Its approval in this setting was based on strong clinical trial results demonstrating a significant survival benefit over chemotherapy. This makes it an important treatment option for patients whose disease has progressed after chemotherapy.

How effective is Libtayo for cervical cancer?

Libtayo has shown significant efficacy in patients with advanced cervical cancer. In the Phase 3 EMPOWER-Cervical 1 trial, which compared Libtayo monotherapy to chemotherapy in patients with recurrent or metastatic cervical cancer, the results were notable:

• Patients receiving Libtayo had a median overall survival of 12.0 months, compared to 8.5 months in the chemotherapy group 9.

These findings positioned Libtayo as an important alternative to chemotherapy, especially for patients whose cancer has progressed following platinum-based treatment.

Is Libtayo available in Poland?

Libtayo was approved in the EU in 2022. However, it didn't immediately become available in Poland. As of January 2025, Libtayo (cemiplimab) should be reimbursed in Poland for cervical cancer.

Previous experience in Poland has shown that the actual availability of medicines added to the reimbursement scheme can take some time or vary based on your location. If you are unable to get Libtayo locally, you may explore Named Patient Import. This pathway allows access to medicines that are not available in your country. For more information, request the medicine below.

Request Libtayo

 

How to get the newest cervical cancer medicines before they're available in Poland?

Whether your doctor has prescribed Tivdak or another of the new medicines for cervical cancer, you can access it, even if it's not available in Poland (yet).

This is possible via the Named Patient Import regulation. It allows patients to buy medicines from abroad, when the medicine:

• has been prescribed by a doctor;
• is not approved or available in the patient's country;
• has no approved and available alternative in the patient's country;
• is for personal use.

If you're looking to start a treatment with the newest cervical cancer immunotherapy, and your doctor has prescribed it, reach out to our expert team at Everyone.org. We'll help you get the best treatment, regardless of where in the world it's available.

 

Get in touch

References:

1.  Cervical cancer in Poland — epidemiology, prevention, and treatment pathways. Oncology in Clinical Practice, Accessed 18 February 2025.
2. Immunoterapia – nadzieja na skuteczniejsze leczenie raka szyjki macicy. Immuno-onkologia.pl, Accessed 18 February 2025.
3. Nowa terapia raka szyjki macicy z pozytywną opinią Rady Przejrzystości. Termedia.pl, Accessed 18 February 2025.
4. FDA Approves Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer. OncLive, Accessed 18 February 2025.
5. EFPIA Patients W.A.I.T. Indicator 2021 Survey. Efpia, Accessed 18 February 2025.
6. Clinical Trial Results in Patients Previously Treated for Advanced Cervical Cancer. Keytruda, Accessed 18 February 2025.
7. Combination therapy clinical trial results. Keytruda, Accessed 18 February 2025.
8. Stage 3 to 4A clinical trial results. Keytruda, Accessed 18 February 2025.
9. Libtayo | European Medicines Agency (EMA). European Medicines Agency, Accessed 18 February 2025.
10. Ta refundacja to fikcja. Obiecany lek na raka dostało pięć pacjentek. Poradnikzdrowie.pl, Accessed 18 February 2025.