Despite new data, the FDA extended the review period for the use of Tarceva in lung cancer until April 2010, following the submission of new data by OSI.

We don't really know what they thought about the data, but the delay could mean they are looking for more robust followup before rendering a decision.

http://www.pipelinereview.com/index.php/2010011532088/Small-Molecules/FD...

These results are very preliminary but suggest a delay in the progression of islet-cell pancreatic cancer. Shares of Pfizer rose on the news. "These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors " said Dr. Mace Rothenberg recently of Pfizer (joined "the dark side" after a nice academic career in clinical oncology). I was his chaperone on tour around Grady Hospital when he came to visit. http://health.usnews.com/articles/health/healthday/2009/03/12/pancreatic...

Gastrointestinal stromal tumor (GIST) is a critical cancer of the gastrointestinal tract. It is also known as soft tissue sarcomas. The prevalence of GIST is likely to be 4 500 - 6 000 new cases per year in the US. Surgery is the normal treatment of local GIST. GIST tumors more often recurs in as many as one of two patients after its initial removal. Repeated GISTs are frequently more persistent than primary tumors with relapses related with lower survival rates. Gleevec is the lone treatment recognized to delay the recurrence of this aggressive cancer.

Lung cancer is the foremost cause of cancer-related deaths in the United States and Europe. The most common type of lung cancer NSCLC occurs from the tissues of the lung. Current treatments are being carried to destroy tumor cells or prevent further tumor growth. Approaches to treatment include surgery chemotherapy biological therapies like monoclonal antibodies and radiation. Avastin and Tarceva are two agents which are targeted against specific proteins that are often found in cancer cells. The proteins are involved in the growth and spread of the cancer cells.

FDA reports Tarceva link to liver damage