FDA Approves Osimertinib Plus Platinum-Based Chemotherapy For Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer

On February 16, 2024, the US Food and Drug Administration (FDA) approved osimertinib plus platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This regulatory decision was based on updated results from the phase 3 FLAURA 2 trial. 

In this open-label trial, 557 patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R-mutations who had not received prior systemic therapy for advanced disease were randomized on a 1-to-1 basis to receive either osimertinib plus platinum-based chemotherapy or osimertinib monotherapy. The major efficacy outcome measure was progression-free survival (PFS), as assessed by the investigator. A key secondary outcome measure was overall survival (OS). 

At analysis, the median PFS was 25.5 months in the chemotherapy arm and 16.7 months in the monotherapy arm (hazard ratio [HR] 0.62; 95% confidence interval [CI]; 0.49 to 0.79; two-sided P-value < .0001). OS results were immature however, 45% of pre-specified deaths for the final analysis were reported, indicating no trend toward a detriment. The most common adverse events, occurring in ≥20% of patients, included leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine. 

The recommended dose of osimertinib is 80 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Source: 

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer. Published February 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer