FDA Modifies Tarceva Indication in Lung Cancer

Treatment is limited to patients with specific EGFR mutations

The FDA has modified the indication for erlotinib (Tarceva, Astellas Pharm Global Development Inc.) for the treatment of non–small-cell lung cancer (NSCLC) to limit the medication’s use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.

The labeling change applies to patients with NSCLC receiving maintenance or second- or greater-line 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.

This labeling supplement is based on the results of the IUNO trial, a randomized, double-blind, placebo-controlled study 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 the study. Participants were randomly assigned to receive erlotinib (n = 322) or placebo (n = 321) orally once daily until disease progression or unacceptable toxicity occurred. After progression on initial therapy, the patients were eligible to enter an open-label phase. Fifty percent of patients treated with erlotinib entered the open-label phase and received chemotherapy, while 77% of patients given placebo entered the open-label phase and received erlotinib.

The trial’s primary endpoint was overall survival. The results demonstrated that survival after 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 impose new post-marketing requirements or request post-marketing commitments based on the results of the IUNO trial.

Source: FDA; October 18, 2016.