Roche to request review of Tarceva rejection

Roche has said it wants the Committee for Medicinal Products for Human Use (CHMP) to review its decision not to recommend Tarceva for the treatment of advanced pancreatic cancer, when used in conjunction with gemcitabine chemotherapy.

The Swiss pharmaceutical company said it was “confident” about the trial results it submitted to the CHMP, the body that recommends treatments to the European Commission for approval.

Roche claims that advanced pancreatic cancer patients who took Tarceva with gemcitabine demonstrated significantly longer survival times than patients who took gemcitabine alone. Furthermore, 24 per cent of Tarceva patients were still alive after a year, compared to 19 per cent using gemcitabine.

Eduard Holdener, head of global drug development, remarked: “Pancreatic cancer is one of the most aggressive forms of cancer and it kills more people within the first year of diagnosis than any other cancer.”

“Given such a poor outlook, even modest improvements in survival are valuable to advanced stage patients,” he added.

Tarceva is already used across the EU for use in patients with metastatic non small cell lung cancer, after other chemotherapy drugs have failed.

Cancer Research UK states that pancreatic cancer is the UK’s 11th most common cancer, with over 3,600 new cases diagnosed in women and 3,300 diagnosed in men every year. The charity estimates that up to a third of cases could be linked to smoking.

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