TGA decision on herceptin
Media statement
21 April 2006
Australia's medicines regulator, the Therapeutic Goods Administration (TGA) has today approved an application by Roche Products Pty Limited to extend the indications of the breast cancer drug Herceptin (trastuzumab) for the treatment of patients with HER2 positive localised breast cancer, but only when used as part of a chemotherapy regimen following surgery.
The trials submitted to support this new use of Herceptin used Herceptin both after and during standard chemotherapy following surgery. Surgery allows the diagnosis of HER2 positive status to be made.
The approval for localised disease refers to use in node-positive disease, or node negative disease with a tumour diameter greater than 20 mm. Herceptin had previously been approved only for later use in advanced breast cancer.
The approval of the application is conditional on updates on the results and data analyses of use of Herceptin and the inclusion of additional information and warning statements in the product information, which have been agreed to by Roche.
Roche has also applied for HERCEPTIN to be listed on the PBS. It is expected that the application for PBS listing will be considered at the July meeting of the Pharmaceutical Benefits Advisory Committee (PBAC).
Media contact: Kay McNiece, Media Adviser to the TGA, 0412 132 585