European committee gives negative ruling on Tarceva

OSI Pharmaceuticals announced that its development partner Roche had been given a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Tarceva in combination with gemcitabine chemotherapy as a first-line oral therapy for advanced metastatic pancreatic cancer. OSI says that Roche may ask for a re-examination of the decision.

"Pancreatic cancer is known to be an aggressive disease that has one of the highest one-year mortality rates of any cancer," said Gabriel Leung, president, (OSI) Oncology. "It is critically important that new treatment options be made available to patients around the globe. Like our partner, Roche, we are disappointed in the CHMP opinion, but we are confident in the clinical profile and benefits of the Tarceva-gemcitabine combination therapy."

- see the release on Tarceva