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

Published on January 17, 2013 at 12:08 AM · No Comments

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."

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment