EC clears Roche's Tarceva in pancreatic cancer

Swiss drug major Roche's Tarceva (erlotinib) has been approved by the European Commission for the treatment of patients with metastatic pancreatic cancer, in combination with a standard chemotherapy, Eli Lilly's Gemzar (gemcitabine HCl). Tarceva, which was co-developed with the USA's OSI, is the first treatment in over a decade to have shown a significant survival benefit in patients with the disease, which has the highest one-year mortality rate of any cancer and is Europe's sixth deadliest cancer. On the day of the news, January 29, shares in OSI rose 0.6% to $33.39, while Roche fell 0.3% to 232.30 Swiss francs.

The approval was based on data from the pivotal PA.3 Phase III study which showed that, for patients with metastatic disease, treatment with Tarceva plus gemcitabine results in significantly longer survival (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, compared to those on chemotherapy alone (21% versus 15%).

The approval follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) last year (Marketletter December 22, 2006).