The Food and Drug Administration (FDA) has changed the indication for Tarceva (erlotinib Astellas) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. 

Specifically, the updated labeling states that the 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. This change applies to patients with NSCLC receiving maintenance or second or greater line treatment.  

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The first-line use was previously limited to patients with EGFR exon 19 deletions or exon 21 substitution mutations. 

Modification of the indication was based on data from the IUNO trial, a randomized, double-blind, placebo-controlled trial of erlotinib given as maintenance therapy in 643 patients with advanced NSCLC who had not experienced disease progression or unacceptable toxicity during 4 cycles of platinum-based first-line chemotherapy; patients with tumors that harbored activating EGFR mutations (exon 19 deletion or exon 21 L858R mutations) were not included in the trial.

Study patients were randomized to either erlotinib or placebo orally once daily until disease progression or unacceptable toxicity. They were eligible to enter the open-label phase following progression on initial therapy. The study’s primary endpoint was overall survival. 

The data indicated survival following treatment with erlotinib was not superior to placebo given as maintenance in patients with metastatic NSCLC tumors not harboring EGFR-activating mutations. In addition, no difference was seen in progression-free survival between the erlotinib vs. placebo groups. 

Tarceva, a kinase inhibitor, is available as 25mg, 100mg, and 150mg strength tablets in 30-count bottles. 

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