OSI Pharmaceuticals, Inc. Announces That Tarceva(R) Received Positive Opinion From Health Authorities In European Union For The Treatment Of Patients With Pancreatic Cancer
Published: Dec 15, 2006
MELVILLE, N.Y.--(BUSINESS WIRE)--OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Roche, its international partner for Tarceva® (erlotinib), announced today that the European Committee for Medicinal Products for Human Use (CHMP), has issued a positive opinion recommending approval of once-daily Tarceva in combination with gemcitabine as first-line therapy for metastatic pancreatic cancer. This recommendation follows a request from Roche for a re-examination of the data supporting the filing for Tarceva in this indication. A final decision is expected from the European Commission within 45 days.