Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR p.L858R status confers therapeutic sensitivity to Osimertinib in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized osimertinib for the adjuvant treatment after complete tumor resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution variants.
This statement is based on a regulatory approval from the European Medicines Agency:
TAGRISSO as monotherapy is indicated for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.