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FDA announces fast track approval of new drug for lung cancer

BMJ 2003; 326 doi: (Published 10 May 2003) Cite this as: BMJ 2003;326:1004
  1. Owen Dyer
  1. London

    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 …

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