Tarceva®’s sNDA Accepted for Filing and Review
The supplemental new drug application (sNDA) for OSI Pharmaceuticals, Inc.’s agent Tarceva® (erlotinib) has been accepted for filing and review by the U.S. Food and Drug Administration (FDA). The sNDA is indicated for Tarceva to be used as first-line maintenance therapy among patients who have not progressed following first-line platinum-based therapy. The review date is scheduled for January 2010. Tarceva targets the human epidermal growth factor receptor 1 (HER1/EGFR).
The sNDA is based upon results from the SATURN study, a phase III international trial in which maintenance therapy with Tarceva improved progression-free survival (PFS) compared with placebo among patients with advanced NSCLC following first-line therapy.
Tarveca is already approved as monotherapy for the treatment of locally advanced or metastatic NSCLC among patients who fail at least one prior chemotherapy regimen. It is also approved, in combination with Gemzar® (gemcitabine) for the treatment of advanced pancreatic cancer.
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