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