Trazimera

trastuzumab

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An overview of Trazimera and why it is authorised in the EU

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

  • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) 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 more than 2 cm wide, Trazimera 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: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).

Trazimera 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.

Trazimera is a ‘biosimilar medicine’. This means that Trazimera is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Trazimera is Herceptin.

Trazimera contains the active substance trastuzumab.

How is Trazimera used?

Trazimera 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 every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer. For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective. The dose depends on the patient’s body weight, on the condition being treated and on whether Trazimera is given every week or every 3 weeks.

The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion. 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 Trazimera, see the package leaflet or contact a doctor or pharmacist.

How does Trazimera work?

The active substance in Trazimera, 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.

What benefits of Trazimera have been shown in studies?

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

In addition, a main study involving 707 patients with metastatic breast cancer that overexpressed HER2 showed that Trazimera was as effective in treating the condition as Herceptin. In this study, 63% of patients given Trazimera had a complete or partial response to treatment compared with 67% of those given Herceptin.

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

What are the risks associated with Trazimera?

The most common or serious side effects with Trazimera are heart problems, reactions related to the Trazimera infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.

Trazimera can cause cardiotoxicity (harm 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.

Trazimera must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients. It must not be used in patients whose advanced cancer causes serious breathing problems even when resting, or who need oxygen therapy.

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

Why is Trazimera authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Trazimera has been shown overall to have a comparable quality, safety and effectiveness to Herceptin. Therefore, the Agency’s view was that, as for Herceptin, the benefit of Trazimera outweighs the identified risk and it can be authorised.

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

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

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

Other information about Trazimera

Trazimera received a marketing authorisation valid throughout the EU on 26.07.2018.

Name Language First published Last updated
Trazimera : EPAR - Medicine overview BG = bălgarski 2018-08-16  
Trazimera : EPAR - Medicine overview ES = español 2018-08-16  
Trazimera : EPAR - Medicine overview CS = čeština 2018-08-16  
Trazimera : EPAR - Medicine overview DA = dansk 2018-08-16  
Trazimera : EPAR - Medicine overview DE = Deutsch 2018-08-16  
Trazimera : EPAR - Medicine overview ET = eesti keel 2018-08-16  
Trazimera : EPAR - Medicine overview EL = elliniká 2018-08-16  
Trazimera : EPAR - Medicine overview EN = English 2018-08-16  
Trazimera : EPAR - Medicine overview FR = français 2018-08-16  
Trazimera : EPAR - Medicine overview IT = italiano 2018-08-16  
Trazimera : EPAR - Medicine overview LV = latviešu valoda 2018-08-16  
Trazimera : EPAR - Medicine overview LT = lietuvių kalba 2018-08-16  
Trazimera : EPAR - Medicine overview HU = magyar 2018-08-16  
Trazimera : EPAR - Medicine overview MT = Malti 2018-08-16  
Trazimera : EPAR - Medicine overview NL = Nederlands 2018-08-16  
Trazimera : EPAR - Medicine overview PL = polski 2018-08-16  
Trazimera : EPAR - Medicine overview PT = português 2018-08-16  
Trazimera : EPAR - Medicine overview RO = română 2018-08-16  
Trazimera : EPAR - Medicine overview SK = slovenčina 2018-08-16  
Trazimera : EPAR - Medicine overview SL = slovenščina 2018-08-16  
Trazimera : EPAR - Medicine overview FI = suomi 2018-08-16  
Trazimera : EPAR - Medicine overview SV = svenska 2018-08-16  
Trazimera : EPAR - Medicine overview HR = Hrvatski 2018-08-16  
Name Language First published Last updated
Trazimera : EPAR - Risk-management-plan summary (English only) 2018-08-16  

This EPAR was last updated on 18/09/2018 .

Authorisation details

Product details

Product details for Trazimera
NameTrazimera
Agency product numberEMEA/H/C/004463
Active substance

trastuzumab

International non-proprietary name (INN) or common name

trastuzumab

Therapeutic area Stomach NeoplasmsBreast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XC03
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Trazimera
Marketing-authorisation holder

Pfizer Europe MA EEIG

Revision1
Date of issue of marketing authorisation valid throughout the European Union26/07/2018

Contact address:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

Product information

14/09/2018  Trazimera -EMEA/H/C/004463 -IAIN/0001

Name Language First published Last updated
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18
Trazimera : EPAR - Product Information EN = English 2018-08-16 2018-09-18

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  
Trazimera : EPAR - All Authorised presentations EN = English 2018-08-16  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Metastatic breast cancer

Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (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

Trazimera is indicated for the treatment of adult patients with HER2 positive early breast cancer. (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 Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic gastric cancer

Trazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Trazimera should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Trazimera : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2018-09-18  

Initial marketing-authorisation documents

Name Language First published Last updated
Trazimera : EPAR - Public assessment report EN = English 2018-08-16  
CHMP summary of positive opinion for Trazimera EN = English 2018-06-01  

Authorised

This medicine is approved for use in the European Union

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