The US Food and Drug Administration (FDA) has accepted Astellas Pharma US, Inc.'s filing 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 tumours 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.

Tarceva is approved for patients with advanced NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). Tarceva is also approved for patients with advanced NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second-/third-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

“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, 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 per cent) people in Western populations with lung cancer and three in 10 (30 per cent) 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 platinumbased chemotherapy in patients with EGFR activating mutation-positive advanced NSCLC.

EGFR is a protein that extends across the cell membrane. The epidermal growth factor (EGF) binds to the part of the EGFR protein that sits on the outside of the cell. Binding leads to activation of the EGFR protein, which triggers a complex signalling cascade inside the cell that leads to events including accelerated cell growth and division and development of metastases (tumour growth and spread to other parts of the body). Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins such that they have increased activity.

Astellas Pharma US, Inc., is a US affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.