Tuznue | European Medicines Agency (EMA)

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Overview

Tuznue is a cancer medicine used to treat the following conditions:

early breast cancer (when the cancer has spread within the breast or to the lymph nodes [‘glands’] under the arm but not to other parts of the body). It is used after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For cancers that are locally advanced (including those that are inflammatory) or tumours more than 2 cm wide, Tuznue is used before surgery in combination with chemotherapy and then again after surgery on its own;
metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own when other treatments have not worked or are not suitable. It is also used in combination with other cancer medicines: paclitaxel or docetaxel, or with another type of medicine called an aromatase inhibitor;
metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).

Tuznue can only be used when the cancer overexpresses HER2. This means that the cancer produces a protein called HER2 in large quantities on the cancer cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.

Tuznue contains the active substance trastuzumab and is a biological medicine. It is a ‘biosimilar medicine’. This means that Tuznue is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Tuznue is Herceptin.

Tuznue can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.

It is given by infusion (drip) into a vein over 90 minutes either once a week or once every 3 weeks for breast cancer and once every 3 weeks for gastric cancer. For early breast cancer, treatment is given for a year or until the disease comes back. For metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.

The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion for signs such as fever and chills. Patients who do not have significant reactions to the first 90‑minute infusion can receive subsequent infusions over 30 minutes.

For more information about using Tuznue, see the package leaflet or contact your doctor or pharmacist.

The active substance in Tuznue, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 from producing signals that cause the tumour cells to grow.

Laboratory studies comparing Tuznue with Herceptin have shown that the active substance in Tuznue is highly similar to that in Herceptin in terms of structure, purity and biological activity. Studies have also shown that giving Tuznue produces similar levels of the active substance in the body to those seen with Herceptin.

In addition, a study involving 502 women with newly diagnosed early breast cancer that overexpressed HER2 showed that Tuznue was as effective as Herceptin in treating the condition. Before surgery to remove the cancer, people were given either Tuznue or Herceptin, each with docetaxel. A complete response (based on no sign of cancer in the breast and lymph nodes in the armpit) was seen in 45% of people treated with Tuznue and 49% of those treated with Herceptin.

Because Tuznue is a biosimilar medicine, the studies on effectiveness of trastuzumab carried out with Herceptin do not all need to be repeated for Tuznue.

The safety of Tuznue has been evaluated and, based on all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Herceptin.

For the complete list of side effects and restrictions of Tuznue, see the package leaflet.

The most common or serious side effects with Tuznue include heart problems, infections, lung and blood problems, and reactions related to the infusion.

Tuznue can cause cardiotoxicity (damage to the heart), including heart failure (when the heart does not work as well as it should). Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.

Tuznue must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or any of the other ingredients. It must not be used in people who have serious breathing problems when they are at rest because of advanced cancer, or who need oxygen therapy.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Tuznue has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way. In addition, studies in early breast cancer have shown that Tuznue and Herceptin are equivalent in terms of safety and effectiveness in treating this condition.

All these data were considered sufficient to conclude that Tuznue will have the same effects as Herceptin in its authorised uses. Therefore, the Agency’s view was that, as for Herceptin, the benefits of Tuznue outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tuznue have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Tuznue are continuously monitored. Suspected side effects reported with Tuznue are carefully evaluated and any necessary action taken to protect patients.

Tuznue received a marketing authorisation valid throughout the EU on 19 September 2024.

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First published: 25/09/2024

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First published: 25/09/2024

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Product information

English (EN)
(539.72 KB – PDF)

First published: 25/09/2024Last updated: 20/02/2025

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Latest procedure affecting product information:
VR/0000250711

20/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(43.91 KB – PDF)

First published: 25/09/2024

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Product details

Name of medicine: Tuznue
Active substance: trastuzumab
International non-proprietary name (INN) or common name: trastuzumab
Therapeutic area (MeSH): Breast Neoplasms
Anatomical therapeutic chemical (ATC) code: L01FD01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Metastatic breast cancer (MBC)

For the treatment of adult patients with HER2-positive MBC:

as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments.
in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable
in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab

Early breast cancer (EBC)

For the treatment of adult patients with HER2-positive EBC:

following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)
following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
in combination with neoadjuvant chemotherapy followed by adjuvant HD201 therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter.

HD201 should only be used in patients with MBC or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic gastric cancer (MGC)

In combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

HD201 should only be used in patients with MGC whose tumours have HER2 overexpression as defined by Immunohistochemistry (IHC) 2+ and a confirmatory silver-enhanced in situ hybridisation (SISH) or fluorescence in situ hybridisation (FISH) result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

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Tuznue | European Medicines Agency (EMA)

Overview

How is Tuznue used?

How does Tuznue work?

What benefits of Tuznue have been shown in studies?

What are the risks associated with Tuznue?

Why is Tuznue authorised in the EU?

What measures are being taken to ensure the safe and effective use of Tuznue?

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Therapeutic indication

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