Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR oncogenic variants status confers therapeutic sensitivity to Gefitinib in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized gefitinib as a monotherapy treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating variants of EGFR-TK.
This statement is based on a regulatory approval from the European Medicines Agency:
IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK.