Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR p.T790M 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 treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.
This statement is based on a regulatory approval from the Food and Drug Administration:
TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.