New Drug Application with the U.S. Food and Drug Administration for Tarceva

OSI Pharmaceuticals and Genentech have announced that OSI completed the submission of a New Drug Application with the U.S. Food and Drug Administration 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.

"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," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "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 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, M.D., 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."

The NDA has been granted Pilot 1 Status under the FDA's Pilot 1 Program for Continuous Marketing Applications, a new program 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 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 percent improvement in median survival and improved one-year survival by 45 percent.

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. 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.