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FDA Modifies the Indication of Erlotinib in Non–Small Cell Lung Cancer to Patients With Specific EGFR Mutations

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On October 18, 2016, the U.S. Food and Drug Administration (FDA) modified the indication for erlotinib (Tarceva) in the treatment of non–small cell lung cancer (NSCLC) to limit its use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.

The labeling change applies to patients with NSCLC receiving maintenance, second-line, or later treatment. These indications will be limited to patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. The first-line indication previously was limited to patients with EGFR exon 19 deletions or exon 21 substitution mutations.

IUNO Trial

This labeling supplement is based on the results of the IUNO trial, a randomized, double-blind, placebo-controlled trial of erlotinib administered as maintenance therapy in 643 patients with advanced NSCLC who had not experienced disease progression or unacceptable toxicity during four cycles of platinum-based first-line chemotherapy. Patients whose tumors harbored activating EGFR mutations (exon 19 deletions or exon 21 L858R mutations) were excluded from this trial.

Patients were randomly assigned 1:1 to receive erlotinib or placebo orally once daily (322 erlotinib, 321 placebo) until disease progression or unacceptable toxicity. Following progression on initial therapy, patients were eligible to enter an open-label phase. Fifty percent of patients randomized to erlotinib entered the open-label phase and received chemotherapy, whereas 77% of patients randomized to placebo entered the open-label phase and received erlotinib. 

The trial’s primary endpoint was overall survival. Results demonstrated that survival following treatment with erlotinib was not better than placebo administered as maintenance in patients with metastatic NSCLC tumors not harboring EGFR-activating mutations. No difference in progression-free survival between the erlotinib arm and the placebo arm was observed.

The FDA will not require new postmarketing requirements or request postmarketing commitments based on the results of the IUNO trial.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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