Supplemental NDA submitted for Tarceva as first-line maintenance therapy in advanced non-small cell lung cancer

OSI Pharmaceuticals and Genentech have announced the submission of a supplemental New Drug Application (sNDA) for the use of Tarceva (erlotinib) as first-line maintenance therapy for patients with non-small cell lung cancer (NSCLC). This sNDA submission is based on a Phase 3 placebo-controlled, double-blind trial known as SATURN.  The trial results showed that Tarceva significantly extended progression-free survival in patients with NSCLC when given immediately following first-line treatment with platinum-based chemotherapy, compared to placebo.

Tarceva is a small molecule designed to target the EGFR pathway, which is one of the factors critical to cell growth in NSCLC and pancreatic cancers.

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