Xeloda gets nod for stomach cancer in Europe

Roche says that its oral cancer drug Xeloda (capecitabine), in combination with platinum-based chemotherapy, has received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for first-line use in patients with advanced stomach cancer.

The positive recommendation is based on results from two Phase III studies, which confirmed that patients on the Xeloda/cisplatin combination lived at least as long without the cancer progressing as those treated with 5-fluorouracil/cisplatin. One of the trials, REAL 2, which is the largest ever Phase III study in advanced gastro-esophageal cancer, demonstrated that Xeloda can replace 5-FU, and that patients treated with the combination of Xeloda plus oxaliplatin and epirubicin lived significantly longer, compared to those treated with standard epirubicin, cisplatin and 5-FU.

"As an oral chemotherapy, Xeloda gives patients a valuable option over the current standard of intravenous treatment," said Ian Chau, of the Gastrointestinal Unit at the Royal Marsden Hospital, Sutton, UK. "Xeloda is as effective as intravenous treatment and reduces the time patients need to spend in the hospital, from five days every three weeks to only one day every three weeks, allowing patients to lead more routine lives and have more personal time. It may also potentially avoid the need of a central intravenous line with its associated inconvenience and complications," he added.