OSI Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Tarceva

OSI Pharmaceuticals, Inc. and Genentech, Inc., today announced that OSI submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for the use of Tarceva (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer (NSCLC: undefined, undefined, undefined%) 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 ..

"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.

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