FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC


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The FDA has approved erlotinib (Tarceva) 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) substitution mutations. This indication for erlotinib was approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection.

Erlotinib Trial

The approval was based on the results of a randomized, multicenter, open-label trial comparing erlotinib to platinum-based doublet chemotherapy in patients with metastatic NSCLC whose tumors had EGFR exon 19 deletions or exon 21 (L858R) substitution mutations determined by a clinical trial assay. Eligible patients were randomly allocated (1:1) to receive erlotinib at 150 mg/day orally, or platinum-based doublet chemotherapy. Randomization was stratified by EGFR mutation and ECOG performance status. Tumor samples from 134 patients were tested retrospectively by the cobas EGFR Mutation Test.

The trial’s primary endpoint was investigator-assessed progression-free survival. Secondary endpoints included overall survival and objective response rate.

The median progression-free survival was 10.4 months in the erlotinib arm and 5.2 months in the platinum-based chemotherapy arm (HR = 0.34, 95% CI = 0.23–0.49); P < .001).  The median overall survival was 22.9 months in the erlotinib arm and 19.5 months in the platinum-based chemotherapy arm (HR = 0.93, 95% CI = 0.64–1.35; P = .6482).

The recommended daily dose of erlotinib for NSCLC is 150 mg taken orally at least 1 hour before or 2 hours after the ingestion of food. ■



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