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OGIVRI (Alphapharm Pty Ltd)
Product name
OGIVRI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
217 working days (255)
Active ingredients
trastuzumab
Registration type
New biosimilar medicine
Indication
OGIVRI (powder for injection) is indicated for the treatment of:
- HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy
- HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant OGIVRI
- patients with metastatic breast cancer who have tumours that overexpress HER2:
- as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;
- in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,
- in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer
OGIVRI is also indicated, in combination with cisplatin and either capecitabine or 5-FU, for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.