FDA Grants Approval to Osimertinib as First-Line Therapy for Metastatic NSCLC With EGFR Mutations
Posted: Monday, April 23, 2018
On April 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for the first-line treatment of patients with metastatic 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 the recently FDA-approved EGFR-Mutation Test v2, to be used as a companion diagnostic test with osimertinib.
Approval was based on the multicenter, international, randomized, double-blind, active-controlled FLAURA trial, which included 556 patients with EGFR exon 19 deletion or exon 21 L858R mutation–positive, unresectable, or metastatic NSCLC who had not received previous systemic treatment for advanced disease. Patients were randomized to receive either osimertinib (orally once daily) or standard-of-care therapy (gefitinib or erlotinib; orally once daily).
The estimated median progression-free survival was 18.9 months in the osimertinib arm and 10.2 months in the standard-of-care arm. The confirmed overall response rate was 77% with osimertinib and 69% with the standard of care. The estimated median response durations for the osimertinib and standard-of-care arms were 17.6 and 9.6 months, respectively. The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite.
