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BCAC Challenges PHARMAC with Updated Herceptin Trial Data
The Breast Cancer Aotearoa Coalition (BCAC) challenges PHARMAC to review recently released Herceptin trial data and give immediate approval to fund Herceptin for use in early stage HER2 positive breast cancer. Herceptin is registered for early breast cancer use in New Zealand but not yet funded here.
New 23-month follow-up data from HERA, one of the largest breast cancer trials ever undertaken, show that Herceptin (trastuzumab) treatment following standard chemotherapy, significantly reduced the risk of death by 34% for women with early-stage HER2-positive breast cancer. The data also show that Herceptin continues to provide a reduced risk of the cancer recurring.
‘Up until now we only had 12 months of data from HERA,’ said Libby Burgess, BCAC Chair, ‘and now here is two years of evidence that Herceptin significantly improves the survival benefits for women suffering from this aggressive cancer that has such a poor prognosis. Many countries have already taken notice and are providing life-saving access to Herceptin for their women, even prior to the licensing of the drug for use in early breast cancer. France, Ireland, Italy and Switzerland are excellent examples. We hope the actions of these countries send a clear message to PHARMAC that time is precious and we need action. We appeal to PHARMAC to consider the new HERA data, provide funded access to Herceptin and start saving the lives of New Zealand women now.’
‘What further information is needed?’ asked Ms Burgess. ‘Why must more women lose their chances and their lives while our government ‘considers’ this issue? If other countries can expedite access, why can’t we? Every month we delay is a national disgrace.’
BCAC has learned that the European Medicines Agency (EMEA) fast-tracked Herceptin and made an initial recommendation for its use within 27 days on April 28th. EMEA was then expected to issue a license for this use approximately 3 months after the recommendation, but the licensing was also fast-tracked and provided within a month on May 24th 2006
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