Therapeutic Response

EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Osimertinib in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Tagrisso (osimertinib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to osimertinib for the adjuvant treatment after tumor resection of adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Tagrisso (osimertinib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to osimertinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Tagrisso (osimertinib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to osimertinib for the treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Tagrisso (osimertinib) [product information]. EMA.

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.
Tagrisso (osimertinib) [product information]. EMA.

The European Medicines Agency (EMA) has authorized osimertinib for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.