Trastucip and Tuzucip
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 July 2021 |
| First round evaluation completed | 25 February 2022 |
| Sponsor provides responses on questions raised in first round evaluation | 9 March 2022 |
| Second round evaluation completed | 4 May 2022 |
| Delegate's overall benefit-risk assessment | 3 May 2022 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 7 July 2022 |
| Completion of administrative activities and registration on ARTG | 18 July 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 216 |
*Statutory timeframe for standard applications is 255 working days
Histidine hydrochloride monohydrate, histidine, trehalose dihydrate, and polysorbate 20
HER2 testing is mandatory prior to initiation of Tuzucip therapy. Dosage of Trastucip and Tuzucip is based on multiple factors including the condition being treated and the body weight of the patient.
For further information refer to the Product Information.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Trastucip and Tuzucip (trastuzumab) was approved for the following therapeutic uses:
Early breast cancer
Trastucip and Tuzucip are 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
Trastucip and Tuzucip are indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant Trastucip and Tuzucip.
Metastatic breast cancer
Trastucip and Tuzucip are 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
Trastucip and Tuzucip are 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.
Trastuzumab has been shown, both in in-vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. In vitro, trastuzumab-mediated antibody dependent cell mediated cytotoxicity (ADCC) has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. In animal models in vivo, murine anti-HER2 antibody inhibited the growth of human tumours overexpressing HER2, indicating that the humanised antibody (trastuzumab) is likely also to have anti-proliferative activity in vivo against human breast tumours expressing high levels of HER2.
- For all injectable products the Product Information must be included with the product as a package insert.