Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ontruzant   
Auth. number : EU/1/17/1241
Active substance : trastuzumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC03 - trastuzumab
(See WHO ATC Index)
Indication: Breast cancer

Metastatic breast cancer

Ontruzant 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

Ontruzant 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) (see section 5.1).

- 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 Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1).

Ontruzant 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 (see sections 4.4 and 5.1).

Metastatic gastric cancer

Ontruzant 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.

Ontruzant 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 (see sections 4.4 and 5.1).
Marketing Authorisation Holder: Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
17/11/2017 Centralised - Authorisation EMEA/H/C/4323 (2017)7747 of 15/11/2017
24/05/2018 Centralised - Notification EMEA/H/C/4323/N/8
Updated with Decision(2018)7553 of 08/11/2018
6/06/2018 Centralised - Variation EMEA/H/C/4323/IB/9
Updated with Decision(2018)7553 of 08/11/2018
13/08/2018 Centralised - Variation EMEA/H/C/4323/IB/11/G
Updated with Decision(2018)7553 of 08/11/2018
16/11/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4323/T/12 (2018)7553 of 8/11/2018
14/02/2019 Centralised - Variation EMEA/H/C/4323/II/0016