Recently, OSI Pharmaceuticals, Inc. (OSIP) announced that the advisory panel of the U.S. Food and Drug Administration (FDA) did not recommend the additional usage of its lung cancer drug Tarceva in patients already responding to chemotherapy. The panel voted 12-1 against using Tarceva as a follow-up therapy in patients who have successfully undergone chemotherapy. The U.S. agency is expected to decide on whether to approve Tarceva for this indication by Jan 18, 2010.
The negative recommendation for the OSIP drug was based on a review of the data from the pivotal late-stage SATURN study (front-line maintenance therapy in non-small cell lung cancer (NSCLC) post-chemotherapy non-progressors), which showed a statistically significant improvement in progression-free survival coupled with overall survival with Tarceva compared to placebo in the NSCLC maintenance setting. However, the panel concluded that the benefit was modest.
OSIP’s Tarceva is already approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (2nd line NSCLC) after the failure of at least one prior chemotherapy regimen.
Tarceva, which  OSIP has co-developed with Genentech now a part of Roche Holdings (RHHBY),  is a small molecule inhibitor of the epidermal growth factor receptor (EGFR) designed to specifically block the activity of the EGFR protein, which is often over-expressed or mutated in many solid cancerous tumors.
As per data of the American Cancer Society, the leading cause of deaths due to cancer in the United States is lung cancer. Most people are diagnosed with advanced stage disease consequently only 15% survive five years. NSCLC is the most common form of lung cancer.
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