According to Roche, Tarceva is the first treatment in over a decade to have shown a significant survival benefit in treating patients with this disease. The approval follows a positive recommendation from the EU in December 2006. Last year a committee advised the EU to reject the drug.
The approval was based on data from a phase III study, which showed that for patients with pancreatic cancer, treatment with Tarceva plus the chemotherapy gemcitabine results in significantly longer survival at 25%, compared to gemcitabine alone.
In addition, a higher percentage of these patients were alive at 12 months in the group treated with Tarceva plus gemcitabine at 21%, compared to those treated with chemotherapy alone at just 15%. Tarceva plus gemcitabine was generally well tolerated by patients
“Tarceva generates renewed optimism for patients and physicians,” said Professor Eric Van Cutsem, of the University Hospital of Gasthuisberg, Belgium. “This approval marks a clear step forward in providing them with another treatment option for battling this terrible disease.”