Overview: Due to promising clinical trial results, Iressa was granted accelerated FDA approval in May 2003. In December 2004, results from a clinical trial showed that Iressa did not provide a survival benefit over placebo for the majority of participants. As a result, in June 2005 the FDA limited use of Iressa to those patients who were benefiting from the treatment, and to use in clinical trials. In July, 2009, Iressa was granted approval in Europe for the treatment of adults with locally advanced or metastatic non-small cell lung cancer whose tumors have tested positively for the EGFR mutation. Clinical trials: Iressa continues to be tested in clinical trials in the United States and remains an approved treatment for non-small cell lung cancer in Europe and in 36 other countries. In August, 2009 the results of a Phase III trial called IPASS (Iressa PanAsia Study), Iressa demonstrated better progression-free survival compared with the combination chemotherapy of carboplatin and paclitaxel. This is the first time a single targeted therapy has shown significantly longer progression-free survival over chemotherapy. Treatment Overview: Common side effects: Special warnings: For more detailed information on treatment with Iressa, side effects, and availability:
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