Herceptin - update
9 February 2006
Australia's medicines regulator, the Therapeutic Goods Administration (TGA) has reaffirmed its readiness to fast track the evaluation of new data to support an application by Roche Products Pty Limited to extend the use of the breast cancer drug Herceptin once the pharmaceutical company provides the information.
On 21 October the TGA received a partial application from Roche to extend the use of Herceptin (trastuzumab) 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.
However, at this stage, Roche has only supplied the TGA and other overseas regulators with preliminary data to support this application and the TGA is awaiting the completed data from Roche.. The preliminary data is already undergoing evaluation.
To properly assess Herceptin for this new indication, the TGA requires full clinical data to ensure that the efficacy and safety of the product have been demonstrated adequately for the proposed use.
Roche previously indicated that it would be in a position to provide the complete data by mid-February 2006.
The TGA stands ready to move quickly once this information is supplied.