Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations. The application has been granted Priority Review status, and an FDA decision is expected in the second quarter of 2013. A pre-market approval (PMA) application for a companion diagnostic, the cobas® EGFR Mutation Test developed by Roche Molecular Diagnostics, has also been submitted to the FDA.

"We are pleased the FDA granted an expedited six-month review of our application because lung cancer is one of the most common and deadly cancers," said Stephen Eck , M.D., Ph.D., vice president, head of Medical Oncology, Astellas Pharma Global Development, Inc. "We are proud of Tarceva's already approved indications for the maintenance and relapsed advanced NSCLC settings. 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."

It is estimated that as many as one in 10 (10 percent) people in Western populations with lung cancer and three in 10 (30 percent) Asian people with lung cancer have EGFR activating mutations. 

The sNDA submission is based on results of the international EURTAC trial, a prospective, randomized, controlled Phase 3 trial evaluating the first-line use of Tarceva versus platinum-based chemotherapy in patients with EGFR activating mutation-positive advanced NSCLC.