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FDA modifies Tarceva indication for NSCLC
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The FDA today modified the indication for erlotinib for patients with previously treated non–small cell lung cancer.
The modification — which applies to patients with NSCLC who receive erlotinib (Tarceva; Genentech, Astellas) as second- or later-line therapy, or as maintenance treatment — limits use of the agent to patients whose tumors harbor EGFR exon 19 deletions or exon 21 L858R substitution mutations as determined by an FDA–approved test.
Erlotinib also is approved for first-line treatment of patients with NSCLC, but that indication already was limited to patients whose tumors harbored the same specific EGFR mutations.
The FDA based the labeling supplement on results of the randomized, double blind, placebo-controlled IUNO trial.
The trial evaluated erlotinib as maintenance therapy in patients with advanced NSCLC who did not experience disease progression or develop unacceptable toxicity during four cycles of first-line platinum-based chemotherapy.
Patients who had exon 19 deletion or exon 21 L858R mutations were excluded from the trial.
Researchers randomly assigned patients to erlotinib (n = 322) or placebo (n = 321) until disease progression or unacceptable toxicity. Upon progression on their assigned therapy, patients had the opportunity to enter an open-label phase of the trial.
Fifty percent of those assigned erlotinib entered the open-label phase and underwent treatment with chemotherapy, whereas 77% of those assigned placebo entered the open-label phase and underwent treatment with erlotinib.
OS served as the primary endpoint.
Results revealed no significant improvement in OS or PFS among those assigned erlotinib compared with placebo.