Sub menu

 
 

TRASTUCIP, TUZUCIP (Cipla Australia Pty Ltd)

Product name
TRASTUCIP, TUZUCIP
Sponsor
Cipla Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
216 (255 working days)
Active ingredients
Trastuzumab
Registration type
NCE/NBE
Indication
Early breast cancer

TRASTUCIP and TUZUCIP are indicated for the treatment of HER2-positive early breast cancerfollowing 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 morechemotherapy regimens for their metastatic disease;
  • in combination with taxanes for the treatment of those patients who have not receivedchemotherapy for their metastatic disease; or
  • in combination with an aromatase inhibitor for the treatment of post-menopausal patientswith 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.

Help us improve the Therapeutic Goods Administration site