Pertuzumab
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer3 | |||
HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Neoadj. | Locally advanced, inflammatory, or early stage; high risk of recurrence |
HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Adj. early | High risk of recurrence |
HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and docetaxel | 1L advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
Full text of section 4.1 (therapeutic indications)
Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in: • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1) • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) 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.
Label history
29 changes to the Perjeta label since 2014, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes