In November 2015, osimertinib received accelerated approval under the Breakthrough Therapy Designation Program for metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC), as detected by an US FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Here, EGFR is linked to non-small cell lung carcinoma.