Page 10 - PHESGO (PERTUZUMAB-TRASTUZUMAB) - Product Monograph

4. TARGET POPULATION FOR FIXED-DOSE SC COMBINATION

OF TRASTUZUMAB AND PERTUZUMAB

The target populations of fixed-dose SC combination of trastuzumab and

pertuzumab are the same as defined for PERJETA - Herceptin in combination
®
®
with chemotherapy in HER2-positive BC and are therefore the same as per the
PERJETA label. 35,39
®

01 Neoadjuvant treatment of HER2-positive eBC patients at high-risk
of recurrence (i.e. lymph node-positive or a tumor size of >2 cm).
35,39

02 Adjuvant treatment of HER2-positive eBC patients at high-risk of
recurrence (at minimum lymph node-positive patients regardless
of HR status) without prior neoadjuvant treatment. 35,39

Adjuvant treatment following neoadjuvant treatment of HER2-
03 positive eBC patients who achieved pathological complete

response (i.e. neoadjuvant treatment continuation). 35,39

04 First-line treatment of HER2-positive mBC patients. 35,39

5. PROPOSED MECHANISM OF ACTION FOR THE FIXED-DOSE

SC COMBINATION OF TRASTUZUMAB AND PERTUZUMAB

5.1. Specially formulated with hyaluronidase 39,44,45

hyaluronidase

trastuzumab

PERJETA ®

Fixed-dose SC combination of trastuzumab and pertuzumab Hyaluronidase is used to deliver pertuzumab and trastuzumab
includes 2 monoclonal antibodies, with recombinant human subcutaneously.
hyaluronidase.
Hyaluronidase allows SC delivery of higher drug volumes.
Fixed-dose SC combination of trastuzumab and pertuzumab is
designed to work with trastuzumab for a dual-HER2 blockade. In Hyaluronidase is an endoglycosidase used to increase dispersion
preclinical models, PERJETA ® targeted a different subdomain on the and absorption of co-administered drugs when administered
HER2 receptor than trastuzumab, to block dimerization with HER1, subcutaneously.
HER3, and HER4 receptors and provide a dual blockade of
HER2-driven signaling pathways.

M-AE-00000086 10