Switzerland’s Roche is celebrating another approval in Europe for its oral chemotherapy treatment Xeloda, this time in advanced stomach cancer.
The Basel-based firm said that the European Commission has approved Xeloda (capecitabine) treatment in combination with platinum-based chemotherapy, for first-line use in patients with advanced stomach cancer. The approval was based on two trials, called ML17032 and REAL 2, which showed that patients on the Xeloda-containing arms lived at least as long overall as those on infusional 5-fluorouracil, and Roche added that the REAL 2 study showed patients on one of the Xeloda-containing arms lived significantly longer than the reference 5-FU part. The treatment is as effective and safe as intravenous treatment, while significantly reducing the time patients need to spend in hospital by 80%, from five days every three weeks to only one day every three weeks, noted the study leader YK Kang of the Asan Medical Center in Seoul, South Korea.
William Burns, head of Roche Pharma, said that stomach cancer is “a particularly aggressive and debilitating type of cancer” and with Xeloda, Roche can provide an effective oral therapy resulting in a cost-effective approach with less hospital visits and more flexibility for the patient". The disease is the second leading cause of cancer-related deaths and every year there are an estimated 911,000 deaths worldwide, with nearly 140,000 in Europe alone.
Xeloda on its own is already available in other gastrointestinal cancers, including colorectal cancer that has spread and post-surgery colon cancer, Roche said, adding that the drug has been filed in the USA for first and second line treatment, with or without Avastin (bevacizumab).