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ONTRUZANT (Samsung Bioepis AU Pty Ltd)

Product name
ONTRUZANT
Sponsor
Samsung Bioepis AU Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
179 working days (255)
Active ingredients
trastuzumab
Registration type
New biosimilar medicine
Indication

ONTRUZANT (powder for injection) is indicated for:

Early Breast Cancer

ONTRUZANT is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.

Locally Advanced Breast Cancer

ONTRUZANT is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant ONTRUZANT

Metastatic Breast Cancer

ONTRUZANT is indicated for the treatment of 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.
Advanced Gastric Cancer

Ontruzant is 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.

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