MANILA, Philippines – Roche announced recently that it has obtained a worldwide sub-license from Genzyme Corp. to develop a diagnostic assay for the detection of Epidermal Growth-Factor Receptor (EGFR) mutations.
At the same time, Roche and OSI Pharmaceuticals Inc. (OSI) have agreed to collaborate on the development of a PCR-based companion diagnostic test to identify people with non-small cell lung cancer (NSCLC) that harbors EGFR-activating mutations.
“The companion diagnostic test will use Roche’s proprietary molecular diagnostics technology,” said Daniel O’Day, head of Roche’s Diagnostic Division.
“The aim is to provide a simple tool that will quickly identify EGFR-activating mutations and to enhance physicians’ ability to customize the use of erlotinib for people with advanced NSCLC,” he said.
Erlotinib has clinically demonstrated a survival benefit in a broad range of patients with advanced NSCLC.
However, tumors with EGFR-activating mutations have been shown to be particularly sensitive to erlotinib.
The identification of patients’ EGFR mutation status would allow physicians to personalize treatment.
Roche has applied to the European Medicines Agency to extend the current label for erlotinib to include the first-line treatment of patients with advanced NSCLC harboring EGFR-activating mutations.