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FDA accepts Astellas supplemental new drug application for Tarceva

PBR Staff Writer Published 17 January 2013

The USFDA has accepted for filing Astellas Pharma's supplemental new drug application (sNDA) for Tarceva (erlotinib) tablets for a genetically distinct form of advanced lung cancer.

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.