EMA — authorised 4 March 2013
- Application: EMEA/H/C/002547
- Marketing authorisation holder: Roche Registration GmbH
- Local brand name: Perjeta
- Indication: Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult 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. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
- Status: approved