FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for erlotinib (Tarceva). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non-small cell lung cancers (NSCLC).
“The approval of the cobas EGFR Mutation Test will allow physicians to identify non–small cell lung cancer patients who are candidates for receiving [erlotinib] as first-line therapy,” said Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient.”
The safety and effectiveness of the cobas EGFR Mutation Test was established with clinical data showing that, on average, patients with NSCLC who have specific types of EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) achieved a progression-free survival of 10.4 months when they received erlotinib treatment, compared to 5.4 months for those who received a standard two-drug chemotherapy regimen. Investigators used tumor samples from the clinical trial to validate the test’s use in this patient population.
New Indication for Erlotinib
The test is being approved with an expanded use for erlotinib as a first-line treatment for patients with metastatic NSCLC who have certain mutations in the EGFR gene.
The approval is erlotinib’s fourth indication and the third use for lung cancer. The FDA approved erlotinib on April 16, 2010, for maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Erlotinib was originally approved in November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
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®.
