Ogivri
trastuzumab
Table of contents
Overview
Ogivri 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, Ogivri 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 type of medicine called an aromatase inhibitor;
metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Ogivri 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.
Ogivri is a ‘biosimilar medicine’. This means that Ogivri is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Ogivri is Herceptin.
Ogivri contains the active substance trastuzumab.
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Ogivri : EPAR - Medicine overview (PDF/84.13 KB)
First published: 09/01/2019
EMA/739554/2018 -
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Ogivri : EPAR - Risk-management-plan summary (PDF/37.57 KB)
First published: 09/01/2019
Authorisation details
| Product details | |
|---|---|
| Name |
Ogivri
|
| Agency product number |
EMEA/H/C/004916
|
| Active substance |
trastuzumab
|
| International non-proprietary name (INN) or common name |
trastuzumab
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01XC03
|
Additional 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. |
Biosimilar |
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 |
Mylan S.A.S
|
| Revision |
3
|
| Date of issue of marketing authorisation valid throughout the European Union |
12/12/2018
|
| Contact address | |
Product information
06/01/2020 Ogivri - EMEA/H/C/004916 - IB/0010
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.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Breast cancer
Metastatic breast cancer
Ogivri 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
Ogivri 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 Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.
Ogivri should only be used in patients with metastatic or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Metastatic gastric cancer
Ogivri 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 gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Ogivri 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.