Posted by Michael Wonder on 23 Aug 2016
TGA publishes AusPAR for pertuzumab (Perjeta)
23 August 2016 - The TGA has published an AusPAR for Roche's HER-2 receptor antagonist pertuzumab (Perjeta).
Pertuzumab was approved by the TGA on 13 May 2016 for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with inflammatory or locally advanced HER2 positive breast cancer as part of a complete treatment regimen.
The approval is based on improvement in pathological complete response rate. No improvement in disease-free, progression-free or overall survival has been shown.
