FDA approves osimertinib for first-line advanced EGFR-mutated NSCLC


The Food and Drug Administration has approved osimertinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.

The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.

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The current approval was based an improved progression-free survival (PFS) in FLAURA, a phase 3 trial of 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. Median PFS was 18.9 months (95% confidence interval, 15.2-21.4) in the osimertinib arm and 10.2 months (95% CI, 9.6-11.1) in the standard-of-care arm of gefitinib or erlotinib (hazard ratio, 0.46; 95% CI, 0.37-0.57; P less than .0001). The confirmed overall response rate was 77% for the osimertinib arm and 69% for the standard-of-care arm, the FDA said in a press statement.

Overall survival was not evaluable at the time of the PFS analysis.

The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).

In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.

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