U.S. Food and Drug Administration grants accelerated approval to Osimertinib for Non-Small Cell Lung

November 13, 2015

The FDA has granted accelerated approval to osimertinib (TAGRISSO) for the treatment of patients with metastatic  “epidermal growth factor receptor”  (EGFR)  T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed after being treated with an EGFR  Tyrosine Kinase Inhibitor (TKI) therapy.  Osimertinib, a drug owned by AstraZeneca Pharmaceuticals, LP, is administered with once daily oral tablets.  The specific mutation in EGFR that determines the drug as an appropriate therapy occurs at position 790 in the amino acid sequence of the protein, and involves an amino acid substitution changing T to M (T790M).   The T790M mutation can be detected in patient tumors using an FDA-approved test. 
 November 13, 2015.  More Information:  http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472565.htm