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OSI Pharmaceuticals Announces Pivotal Phase III Tarceva Study,Published in the Journal of Clinical Oncology Showed Survival,Improvement in Patients with Pancreatic Cancer

Safety Profile

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer, or other advanced solid tumors. In the pancreatic cancer trial, other serious adverse events associated with Tarceva, and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia. The most common side effects in patients with pancreatic cancer receiving Tarceva (100 mg) plus gemcitabine were fatigue, rash, nausea, anorexia, and diarrhea. Severe rash (5%) and severe diarrhea (5%) each resulted in dose reductions in 2% of patients, and discontinuation in up to 1% of patients. The most common side effects in patients with NSCLC receiving Tarceva monotherapy (150 mg) were mild to moderate rash (9%) and diarrhea (6%) which resulted in 1% of Tarceva-treated patients discontinuing therapy. When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding.

About OSI Pharmaceuticals

OSI Pharmaceuticals is committed to "shaping medicine and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company's oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI's diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva(R) (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarcev
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