Astellas is seeking approval to use Tarceva as the first-line therapy to treat patients with EGFR activating mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The sNDA, which was granted priority review status, included data from EURTAC trial, a randomized, controlled Phase 3 study designed to assess the use of Tarceva compared to platinum-based chemotherapy in NSCLC patients with EGFR activating mutations.
Astellas Pharma Global Development medical oncology head, vice president Stephen Eck said the FDA granted an expedited six-month review of the application.
"We are proud of Tarceva’s already approved indications for the maintenance and relapsed advanced NSCLC settings," Eck added.
"If approved, people with a genetically distinct form of lung cancer could have a potential new personalized medicine for use as a first-line treatment."
The cobas EGFR Mutation Test, developed by Roche Molecular Diagnostics, is a companion diagnostic for which a pre-market approval application was also submitted to the regulatory body.