Astellas Pharma US is seeking FDA approval for Tarceva tablets to treat non-small cell lung cancer patients (NSCLC) with tumors containing epidermal growth factor receptor (EGFR) that triggers mutations.
The company submitted a supplemental new drug application (sNDA) based on the data from randomized, controlled Phase 3 EURTAC trial conducted in patients with EGFR triggering mutation-positive advanced NSCLC.
Tarceva demonstrated a consistent safety profile and minimized the risk of lung cancer worsening by 66% in the study.
Center for Devices and Radiological Health (CDRH) is presently reviewing the cobas EGFR Mutation test that is expected to support the Tarceva sNDA.
New test was developed by Roche Molecular Diagnostics to detect NSCLC patients with tumors containing EGFR activating mutations.
