Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR oncogenic variants status confers therapeutic sensitivity to Erlotinib in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized erlotinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating variants. Erlotinib's production information further states that factors associated with prolonged survival should be taken into account when prescribing erlotinib. It further states that no survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumors.
This statement is based on a regulatory approval from the European Medicines Agency:
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.