Following the problems the firm has had to face with its lung cancer offering, Iressa (gefitinib) [[28/06/05f]], [[20/06/05a]], AstraZeneca has received a major fillip as another of its oncology drugs, Arimidex (anastrazole), has been granted a licence extension in Europe.
The Medicines and Healthcare products Regulatory Agency in the UK, which has acted as the reference member state for the European mutual recognition procedure, has approved the use of Arimidex in postmenopausal women who have undergone surgery for a type of breast cancer fuelled by oestrogen. About 75% of all postmenopausal cases of breast cancer fall into this category, AstraZeneca noted.
The licence extension has been granted as a result of findings from the 9,000-patient ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial [[09/12/04b]], which showed that Arimidex, an aromatase inhibitor, reduced the risk of breast cancer recurring anywhere in the body by an additional 26% over and above the 50% reduction provided by gold standard treatment tamoxifen.
The decision means that thousands more women are now eligible for the drug straight after surgery. Said Rob Carpenter, consultant surgical oncologist at St Bart’s in London: “This is the moment we have been waiting for… this news marks the beginning of a whole new era in breast cancer management.” However, it may be some time before the treatment is made routinely available, as Arimidex costs much more than tamoxifen and the National Institute for Health and Clinical Excellence has not yet issued guidance on its use.
Somewhat surprisingly, Novartis, which sells a competing aromatase inhibitor called Femara (letrozole) issued a statement welcoming the decision, saying “this demonstrates yet another advancement in the treatment of breast cancer with AIs and gives continued hope for those affected.”
In terms of sales, AstraZeneca will be hoping to see turnover of the drug rise from the $811 million banked in 2004, up 56% on the previous year, but analysts are being cautious as to how high the increase will be, given the cost issue.