Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Osimertinib in patients with Non-Small Cell Lung Cancer.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
TAGRISSO is a kinase inhibitor indicated for adjuvant therapy after tumor resection in 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.