OSI PHARMACEUTICALS SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION TO THE FDA FOR TARCEVA AS A FIRST-LINE MAINTENANCE THERAPY IN ADVANCED NON-SMALL CELL LUNG CANCER
Roche Submits Marketing Authorization Application for Approval of Tarceva as a First-line Maintenance Therapy in Europe
March 18, 2009 Melville, New York and South San Francisco, Calif. – OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Genentech, Inc., (NYSE:DNA) today announced that OSI submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Tarceva® (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Additionally, the Companies announced that Roche, their international collaborator for Tarceva, filed an application in Europe with the European Medicines Agency (EMEA).
“If approved, Tarceva will be the first EGFR targeted and oral therapy available as a first-line maintenance treatment for people with NSCLC, which we believe is an important advancement in the treatment of lung cancer,” stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals.
“The FDA application reflects our goal of extending the time people with advanced lung cancer live without their disease progressing following initial treatment with chemotherapy,” said Hal Barron, M.D., Genentech’s senior vice president, Development and chief medical officer.
Both the U.S. and EU submissions are based on a pivotal Phase III placebo-controlled, randomized, double-blind trial known as SATURN. In November 2008, OSI, Genentech and Roche announced that SATURN met its primary endpoint and showed that Tarceva significantly extended the time patients with advanced NSCLC lived without their cancer getting worse (progression-free survival or PFS) when given immediately following initial treatment with platinum-based chemotherapy, compared to placebo. There were no new or unexpected safety signals in the study and adverse events were consistent with those observed in previous NSCLC clinical trials evaluating Tarceva.
The SATURN data will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology being held May 29-June 2, 2009 in Orlando, Fla. Overall survival data, a secondary endpoint of the study, are expected in the second half of 2009 and will be part of the FDA review process.
Additional Information about SATURN
The SATURN study, conducted by Roche, enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with at least four cycles of standard first-line platinum-based chemotherapy and were then randomized to Tarceva or placebo if their cancer did not progress. The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, safety and an evaluation of exploratory biomarkers.
About Lung Cancer
According to the American Cancer Society (ACS), lung cancer is the single largest cause of cancer death among men and women in the U.S. and nearly 162,000 Americans died from the disease in 2008. Most people with lung cancer are diagnosed with advanced stage disease that cannot be surgically removed or has spread to other parts of the body. The majority of people with advanced lung cancer survive less than one year. NSCLC is the most common type of lung cancer.
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