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FDA Approves Osimertinib Following Chemoradiation for Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer Harboring EGFR Mutations
On September 25th, 2024, the US Food and Drug Administration (FDA) approved osimertinib for patients with locally advanced, unresectable stage 3 non-small lung cancer (NSCLC) harboring EGFR-exon 19 deletions or EGFR-exon 21 L858R mutations who do not experience disease progression on or after concurrent or sequential platinum-based chemoradiation. This approval was based on efficacy results from the LAURA trial.
In this double-blind, placebo-controlled trial, 216 patients were randomized within 42 days of chemoradiation completion on a 2-to-1 basis to receive either 80 mg of osimertinib once daily or placebo until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Key secondary end points included overall survival (OS) and safety.
At analysis, median PFS was 39.1 months in the osimertinib arm and 5.6 months in the placebo arm. OS data was immature at analysis with 36% of pre-specified deaths reported at that time. The most common adverse reactions (including laboratory abnormalities) occurring in ≥ 20% of patients included lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
The recommended dose of osimertinib is 80 mg once daily with or without food until disease progression or unacceptable toxicity.
Source:
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. Accessed on September 25, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer
