Australia’s medicines regulator, the Therapeutic Goods Administration (TGA) is considering a recommendation by its expert committee, the Australian Drug Evaluation Committee (ADEC), to conditionally approve an application by Roche Products Pty Limited to extend the registration of the breast cancer drug Herceptin (trastuzumab) for use in HER2 positive localised breast cancer in addition to chemotherapy.

The recommendation is conditional on regular (no more than 12 monthly) updates on the results and data analyses of use of Herceptin.

The ADEC also recommended that the warnings in the Product Information (PI) document for all health professionals and the Consumer Medicine Information (CMI) document for patients be strengthened.

The application by Roche seeks to extend the use of Herceptin to include the treatment of women with early breast cancer who are HER2 positive and have undergone surgery and completed chemotherapy. At present Herceptin is only registered for use in advanced breast cancer.

The TGA will make the final decision as soon as matters, such as the amended product information, are agreed to by the company.

http://www.tga.gov.au/