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 Collections under
which this article appears: Chemotherapy
Cancer: lung
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London Owen Dyer
The US Food and Drug Administration this week approved AstraZeneca’s new cancer drug gefitinib (Iressa), the first of a new class of cancer drugs billed as a well tolerated alternative to conventional chemotherapy. But the approval for use in non-small cell lung cancer was conditional on further studies, and the drug will not be prescribed for first line treatment as originally intended.
Gefitinib belongs to a class of drugs known as epidermal growth factor receptors, which block signals in cancer cells that promote growth. It was approved in Japan in July 2002, but the manufacturer’s claims of tolerability were called into question after the drug was blamed for 246 deaths from interstitial lung disease.
Sales in Japan fell from $41m (£26m; €36m) in the last quarter of 2002 to $19m in the first quarter of 2003. The Japanese health ministry, however, has said that the benefits of gefitinib continue to outweigh the dangers and that the rate of adverse events fell dramatically this year after new guidelines for use were introduced.
The US trials were phase II trials, which are deemed sufficient for fast-track FDA approval of treatments for life-threatening diseases, on condition that the manufacturer undertakes to perform post-marketing "phase IV" trials. The FDA said its approval was based on a 142-patient trial in which gefitinib reduced tumour size by more than 50% in 10.6% of subjects, with a median response duration of seven months. The drug was significantly more effective in women than in men. It was also more effective in patients who had never smoked. FDA associate director for medical policy Robert Temple, announcing the drug’s approval, said the drug produced a "low but real response rate."
Larger trials studying gefitinib in conjunction with standard platinum-based chemotherapy showed no additional benefit. As a result, the drug has only been approved for use in patients who show no response to platinum-based and docetaxel chemotherapy. Phase II trials are now underway for possible applications in colorectal, breast, head and neck and prostate cancers.
About 23,000 American patients have taken gefitinib, many under an expanded access programme (www.fda.gov/cder/foi/label/2003/021399lbl.pdf). The FDA found that American patients suffered fewer adverse events than Japanese patients, with only about 0.3% developing insterstital lung disease compared to 2% in Japan.
British based AstraZeneca saw a sharp rise in its US share value following the announcement, as the markets had been far from optimistic about gefitinib’s prospects. AstraZeneca’s position in the US market was under threat as its bestselling acid reflux drug omeprazole (marketed in the US as Prilosec and in Britain as Losec) has lost 60% of its sales this year to generic competitors.
Two weeks ago, Australia became the second country to approve gefitinib, and
an application was submitted to the European Union in February. The once a day
pill will cost about $1900 a month in the United States.
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Cancer: lung
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