Roche has received a fresh approval from regulators in Europe for its blockbuster Xeloda as part of a combination therapy for colon cancer.

The European Medicines Agency has given the green light to Xeloda to be used in combination with oxaliplatin (marketed as Eloxatin by Sanofi-Aventis) for the adjuvant treatment of patients with early colon cancer. The approval was based on results from a 1,886-patient Phase III study which demonstrated that patients taking the combo, known as Xelox immediately after surgery, lived disease-free for longer compared to those on the commonly-used chemotherapy combination 5-fluorouracil/leucovorin. Three-year disease-free survival for patients receiving Xelox was superior to the 5-FU/LV arm (71.0% versus 67.0%).

Pascal Soriot, chief operating officer at Roche’s pharmaceutical division, said patients will now have the added benefits and convenience of oral Xeloda in combination therapy for this disease, which is potentially curable if diagnosed and treated promptly”. Following approval in the European Union, label extensions for Xelox in other regions of the world are expected, Roche added.

This latest thumbs-up will boost the already-strong sales of Xeloda which reached about $1.2 billion last year. It is approved for a wide range of cancers, including colorectal, gastric and breast, and has been available as a monotherapy for use immediately after surgery in patients with colon cancer in Europe and the USA since 2005.