Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 29 January 2018

Indication(s)

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).
- 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.

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.


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

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Category Value
Agency product number EMEA/H/C/004323
Orphan designation No
Date First Approved 15-11-2017
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Samsung Bioepis UK Limited (SBUK)