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OSI Pharmaceuticals: Roche Has Received Negative CHMP Opinion in European Union on Tarceva(R) in Pancreatic Cancer

01 Aug 2006 - OSI Pharmaceuticals, Inc. announced that Roche, its international partner for Tarceva(R) (erlotinib), received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP), regarding approval of Tarceva in combination with gemcitabine chemotherapy as first-line, once-daily, oral therapy for locally advanced, inoperable or metastatic pancreatic cancer. Roche is evaluating its options - including a possible request for re-examination of the decision.
 
Pancreatic cancer, the tenth most frequently occurring cancer in Europe, has extremely limited treatment options. In the past nine years, the Tarceva-gemcitabine combination has been the only treatment regimen to have shown, in a Phase III clinical trial, a statistically significant improvement in overall survival when administered as initial therapy to patients suffering with advanced pancreatic cancer. In November 2005, the U.S. Food and Drug Administration (FDA) approved the use of Tarceva in combination with gemcitabine chemotherapy for the treatment of locally advanced unresectable or metastatic pancreatic cancer in patients who have not received previous chemotherapy. In addition, Tarceva is currently approved in the U.S. and the European Union, as well as approximately 50 countries worldwide, as a monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.