Roche Wants New Ruling On Tarceva

Law360, New York (September 5, 2006, 12:00 AM EDT) -- Swiss drug maker Roche has asked European health authorities to reexamine the data regarding its pancreatic cancer medicine, Tarceva, in light of a recent negative ruling.

Roche first announced over a month ago that the European Committee for Medicinal Products for Human Use (CHMP) had rejected its Tarceva application.

Specifically, the application, first filed with the CHMP in October 2005, was for Tarceva in combination with gemcitabine chemotherapy. According to a study sponsored by Roche, 24% of patients taking Tarceva plus gemcitabine were alive after one...
To view the full article, register now.