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