Zercepac

RSS

trastuzumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Zercepac 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) 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, Zercepac 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).

Zercepac 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.

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

Zercepac contains the active substance trastuzumab.

This EPAR was last updated on 09/02/2023

Authorisation details

Product details
Name
Zercepac
Agency product number
EMEA/H/C/005209
Active substance
trastuzumab
International non-proprietary name (INN) or common name
trastuzumab
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Stomach Neoplasms
Anatomical therapeutic chemical (ATC) code
L01FD01
Additional monitoringAdditional monitoring

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

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
27/07/2020
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona
SPAIN

Product information

07/02/2023 Zercepac - EMEA/H/C/005209 - IA/0025

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Metastatic breast cancer

Zercepac 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

Zercepac 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 Zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

Zercepac 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

Zercepac 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.

Zercepac 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

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