TGA approval of herceptin

22 June 2006

The TGA recently approved an extension of the use of Herceptin (trastuzumab) for use in localised breast cancer, in women with either a primary tumour greater than 20mm in size or with lymph node involvement. This restriction was applied because the data supplied to the TGA only give confidence that the risks of treatment are outweighed by the potential benefits in terms of reduction in recurrence in women meeting this description. Data on women with primary tumours less than 20 mm in size and no lymph node involvement were not provided to the TGA. In reaching this decision, the TGA consulted with the experts of the Australian Drug Evaluation Committee (ADEC), who recommended that the data supported use in those who meet the criteria of a primary tumour greater than 20mm or lymph node involvement.

The sponsor company has accepted this decision.