At present Herceptin is only registered for use in advanced breast cancer. Roche had submitted a partial application to the Therapeutic Goods Administration (TGA) to extend the use of Herceptin to include the treatment of women with early breast cancer who are HER-2 positive and have undergone surgery and completed chemotherapy.
Roche has since submitted additional data to enable the TGA assessment of its application to proceed. The TGA is now reviewing the clinical data to assess if the efficacy and safety of the product is satisfactory for this additional use.
Following completion of the evaluation, the TGA will consult with the experts of the advisory committee, the Australian Drug Evaluation Committee (ADEC). On receipt of the advice from the ADEC, a senior TGA official will consider all the information and make a decision regarding the approval of Herceptin for early use.
The TGA has assigned a priority status to the application and said it will conduct the evaluation as quickly as possible. If all goes to plan, it is expected that the evaluation will be completed within three months, which is less than one-third of the normal processing time.