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EU approves Roche stomach cancer drug

The European Commission has approved Roche's drug Xeloda in combination with platinum-based chemotherapy, for first-line use in patients with advanced stomach cancer.

Oral chemotherapy Xeloda is already replacing standard intravenous therapy 5-fluorouracil (5-FU) in other gastrointestinal cancers. Xeloda on its own is already available in colorectal cancer that has spread and post-surgery colon cancer.

“Not only is capecitabine as effective and safe as intravenous treatment but it also reduces the time patients need to spend in hospital by 80%, from five days every three weeks to only one day every three weeks,” said professor Y.K. Kang of the Asan Medical Center, Seoul, South Korea.

“Up to now, the standard treatment has involved using intravenous pumps which the patients find inconvenient and uncomfortable. As an oral drug, capecitabine can be taken in the comfort of your own home, making it much more convenient.”

The approval of Xeloda in combination with platinum-based chemotherapy (with or without epirubicin), was based on two trials. Both these trials showed that patients on the Xeloda-containing arms lived at least as long overall as those on the 5-FU arms. One of the studies showed that patients on one of the Xeloda-containing arms lived significantly longer than the reference 5-FU arm.