Product Dossier
TRASTUCIP
Product Dossier for TRASTUCIP (Trastuzumab, Cipla). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Cipla
- Active ingredient: Trastuzumab
- Therapeutic area: Oncology
- Related brand: OGIVRI
- Related brand: HERCEPTIN
- Related brand: TUZUCIP
- Same area: TALZENNA
- Same area: ZARZIO
What it is
TRASTUCIP is trastuzumab 150 mg powder for injection.
Approved indications
— Treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy. — Treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy. — Treatment of patients with metastatic breast cancer who have tumours that overexpress HER2 as monotherapy for those who have received one or more chemotherapy regimens for their metastatic disease. — Treatment of patients with metastatic breast cancer who have tumours that overexpress HER2 in combination with taxanes for those who have not received chemotherapy for their metastatic disease. — Treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer and HER2-overexpressing tumours in combination with an aromatase inhibitor. — 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, in combination with cisplatin and either capecitabine or 5-FU.
Regulatory history
TRASTUCIP was first listed on the ARTG on 18 July 2022. The approval date was 7 July 2022.