Pertuzumab + trastuzumab

Pertuzumab + trastuzumab (Phesgo, Roche Registration GmbH) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: HER2 (3).
Approved indications of Pertuzumab + trastuzumab
Biomarker requirementRegimenSettingConditions
Breast cancer3
HER2 IHC 3+ or IHC 2+/ISH-positive
+ chemotherapy
Neoadj.
Locally advanced, inflammatory, or early stage; high risk of recurrence
HER2 IHC 3+ or IHC 2+/ISH-positive
+ chemotherapy
Adj.
early
High risk of recurrence
HER2 IHC 3+ or IHC 2+/ISH-positive
+ docetaxel
1L
advanced
No prior anti-HER2 therapy or chemotherapy for metastatic disease
Full text of section 4.1 (therapeutic indications)

Early breast cancer (EBC) Phesgo is indicated for use in combination with 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 (MBC) Phesgo is indicated for use in combination with 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

8 changes to the Phesgo label since 2022, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes