FDA Restricts Tarceva Maintenance Treatment to Tumors with Specific Mutations

The FDA limited the indications for Tarceva (erlotinib), developed by Astellas Pharma, for patients with non-small cell lung cancer tumors that have specific mutations.

In patients receiving maintenance or second-line or greater treatment, the drug’s indication will now be limited to patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. In April 2010, the FDA approved Tarceva as a single agent maintenance treatment for patients with advanced non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based, first-line chemotherapy.

The FDA based the label change on the results of a Phase III trial, which demonstrated that, in patients who did not have EGFR-activating mutations, taking Tarceva maintenance therapy did not improve overall or progression-free survival compared to placebo. The FDA said it will not impose new post-marketing requirements or request post-marketing commitments based on the results of the trial.