Roche announces positive CHMP opinion for Xeloda

Roche has announced that Xeloda (capecitabine) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of advanced gastric cancer in conjunction with platinum-based chemotherapy.

This recommendation is passed on the results of the ML17032 and Real 2 phase III clinical trials. The first of these showed that patients administered with Xeloda and cisplatin combination lived as long without cancer progression as those receiving 5-FU with cisplatin.

Real 2 showed that patients administered with Zeloda plus oxaliplatin and epirubicin lived longer than patients treated with 5-FU, cisplatin and epirubicin.

Dr Ian Chau, of the gastrointestinal unit at the department of medicine in the Royal Marsden Hospital, said: “As an oral chemotherapy, Xeloda gives patients a valuable option over the current standard of intravenous treatment.”

He added that the compound is as effective as intravenous therapy, while patients can reduce the time to one day every three weeks, down from five days.

Last December, Roche announced that Xeolda had met its primary endpoint of progression-free survival in an international phase III clinical trial.

The study showed that Xeloda plus oxaliplatin is as effective in delaying the progression of colorectal cancer as infused 5-FU/leucovorin plus oxaliplatin.