Herceptin - update
1 March 2006
Australia's medicines regulator, the Therapeutic Goods Administration (TGA) has commenced the evaluation of an application by Roche Products Pty Limited to extend the use of the breast cancer drug Herceptin (trastuzumab).
Roche had submitted a partial application to the 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. At present Herceptin is only registered for use in advanced breast cancer. Roche has now submitted additional data to enable the TGA assessment of their 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. The evaluation process requires the clinical evaluator to evaluate and analyse all of the data submitted with the application and prepare a clinical evaluation report. The amount of data submitted with the application is over 5,000 pages of detailed scientific data. All medicines have risks as well as benefits and the balance can vary for different uses, so it is important to review the submission data.
Following completion of the evaluation the TGA will consider the report and 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 time taken to reach a decision on any application is heavily dependent on the ability of the sponsor to work with the TGA during the evaluation process.
The TGA has assigned a priority status to the application and will conduct the evaluation as quickly as possible. If all goes well, it is expected that the evaluation will be completed within three months, which is less than one-third the normal processing time.
The Pharmaceutical Benefits Advisory Committee can consider a submission from a drug's sponsor for listing on the Pharmaceutical Benefits Scheme once the drug is approved for use by the TGA. While some of the preparatory work of the PBAC can occur simultaneously with a TGA evaluation, it cannot be finalised until after the TGA makes its decision. If the evaluation of Herceptin by the TGA proceeds as expected, it is likely that the PBAC will be in a position to make a recommendation to government in July 2006 regarding the possible listing of Herceptin on the PBS.