OSI Pharmaceuticals Inc and Genentech Inc announced that OSI completed the submission of a New Drug Application (NDA) with the US FDA for Tarceva (erlotinib HCl), as a monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) for whom chemotherapy has failed.

The NDA filing is based on a pivotal Phase III double-blind, placebo-controlled trial that included 731 patients and that compared Tarceva to placebo in the treatment of patients with relapsed non-small cell lung cancer who had previously received chemotherapy. Tarceva demonstrated a 42 per cent improvement in median survival and improved one-year survival by 45 per cent.

The study also demonstrated statistically significant improvement in all secondary endpoints of the trial including time to symptom deterioration, progression-free survival and response rate. The study results make Tarceva the first and only targeted therapy to demonstrate an improvement in survival for non-small cell lung cancer patients. Detailed results of the trial were presented in June at the 40th Annual American Society of Clinical Oncology (ASCO) meeting in New Orleans, LA.

"This submission completes the Tarceva NDA filing and is a major milestone in our commitment to providing relapsed lung cancer patients with this potential new treatment option as quickly as possible," Colin Goddard, CEO of OSI Pharmaceuticals stated adding, "We are proud of the efforts of our internal clinical and regulatory teams in completing our first NDA in a timely manner and we appreciate the support of the Genentech team in this process. We will continue to work closely with the FDA as it reviews the Tarceva application."

The NDA has been granted Pilot 1 Status under the FDA's Pilot 1 programme for Continuous Marketing Applications, a new programme designed for investigational products that have been given Fast Track status, such as Tarceva, and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition.

"The improvement in survival observed in the Tarceva pivotal trial represents an important medical advance in the treatment of non-small cell lung cancer," said Hal Barron, Genentech's senior vice president, development and chief medical officer. "Of note, Tarceva showed improvement in survival across a broad spectrum of patients in the pivotal study and we believe, if approved, it will provide an important potential treatment option," he added.

The global study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University in collaboration with OSI Pharmaceuticals.

Tarceva is designed to block tumour cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor thereby blocking the HER1/EGFR signalling pathway inside the cell. Tarceva is currently being evaluated in an extensive clinical development programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche.

According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the United States and is responsible for nearly 30 per cent of cancer deaths in the country. NSCLC is the most common form of lung cancer and accounts for almost 80 per cent of cases.