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PHESGO SC (Roche Products Pty Ltd)
Product name
PHESGO SC
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
197 (255 working days)
Active ingredients
pertuzumab; trastuzumab
Registration type
EOI
Indication
New combination
Early Breast Cancer (EBC)
PHESGO SC (solution for injection) is indicated in combination with chemotherapy for the:
- neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer
- adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence
Select patients for therapy based on a validated test.
Metastatic Breast Cancer (MBC)
PHESGO SC is indicated in combination with docetaxel for patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Select patients for therapy based on a validated test.