Lung Cancer
Volume 69, Issue 3 , Pages 265-271, September 2010

Rationale of a relaunch of gefitinib in Caucasian non-small cell lung cancer patients

  • Andreas Pircher

      Affiliations

    • Medical University Innsbruck, Department of Internal Medicine V, Hematology and Oncology, Anichstrasse 35, 6020 Innsbruck, Austria
    • Corresponding Author InformationCorresponding authors. Tel.: +43 512 504 82430; fax: +43 512 504 26299.
    • ,
  • Ferdinand Ploner

      Affiliations

    • Medical University Graz, Department of Oncology, Auenbruggerplatz 15, 8036 Graz, Austria
    • ,
  • Helmut Popper

      Affiliations

    • Medical University Graz, Institute of Pathology, Auenbruggerplatz 15, 8036 Graz, Austria
    • ,
  • Wolfgang Hilbe

      Affiliations

    • Medical University Innsbruck, Department of Internal Medicine V, Hematology and Oncology, Anichstrasse 35, 6020 Innsbruck, Austria
    • Corresponding Author InformationCorresponding authors. Tel.: +43 512 504 82430; fax: +43 512 504 26299.

Received 30 September 2009; received in revised form 18 January 2010; accepted 24 January 2010. published online 19 February 2010.

Abstract 

In 2002 results of two-phase II studies with the new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) gefitinib showed not only promising efficacy in second and third line non-small cell lung cancer (NSCLC) therapies but also an excellent tolerability. Since then, thousands of patients have been treated in one of the largest expanded access programs ever performed and the successful application in daily routine led to a preliminary approval of the drug by the U.S. Food and Drug Administration in 2003. In the light of the negative results of a subsequent phase III trial comparing gefitinib with best supportive care, the approval was withdrawn. In 2009 gefitinib was relaunched for Caucasian patients in the US and Europe based on new data and on the re-interpretation of previous studies. The approval is now recommended exclusively for patients with an activating EGFR mutation. For the first time in lung cancer, molecular work-up is of clinical relevance and will change the diagnostic and therapeutic algorithms. The present review summarizes these data, presents the rationale for this development and proposes a diagnostic work-up.

Keywords: Gefitinib, Non-small cell lung cancer (NSCLC), EGFR tyrosine kinase inhibitor (TKI), EGFR mutations

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PII: S0169-5002(10)00060-7

doi:10.1016/j.lungcan.2010.01.017

Lung Cancer
Volume 69, Issue 3 , Pages 265-271, September 2010

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