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Herceptin - update, 14 November 2005
14 November 2005
On 21 October the Therapeutic Goods Administration (TGA) received an application from Roche Products Pty Limited to extend the use of the breast cancer drug, 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 with very limited and preliminary data to support this application. To properly assess Herceptin for this new indication, the TGA requires full clinical data to ensure that the quality, efficacy and safety of the product have been demonstrated adequately for the proposed use.
Roche has advised the TGA and overseas regulatory authorities that the completed information supporting the new indication will not be available until early 2006.