Oncology Drug Reference Sheet: Osimertinib

Osimertinib (Tagrisso^®) received its first U.S. Food and Drug Administration (FDA) approval for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have EGFR T790M variants in November 2015. Since then, the FDA has expanded its approval to other EGFR variants, including exon 19 deletions and exon 21 L858R variants. In the drug’s clinical trial, patients taking osimertinib alone experienced slower disease progression, with a median overall survival of 38.6 months.