Swiss drug giant Roche said today it has filed its established oral cancer pill Xeloda with European regulators for the treatment for stomach cancer, an illness which claims the lives of almost 140,000 Europeans every year.
The filing is based on findings – from the first ever late-stage clinical trial comparing a regimen of Xeloda (capecitabine)/cisplatin against the gold standard therapy, infusional 5-fluorouracil – which showed that patients given Roche’s drug lived at least as long without their disease progressing as those taking 5-FU. Moreover, for the first time in any cancer, the response rate was superior to the standard therapy.
And a further advantage Xeloda would bring to patients is its simplified administration; being an oral medicine, it greatly reduces the amount of trips to hospital needed compared with 5-FU. “These new robust data are very encouraging – for the first time, a viable alternative to the current standard intravenous treatment will become available for stomach cancer patients in Europe,” commented lead investigator Professor YK Kang of the Asan Medical Center, Seoul, South Korea.
Xeloda is already approved in several countries for colorectal, colon and breast cancer, and in South Korea for the treatment of stomach cancer that has spread. The drug pulled in sales of 796 million Swiss francs ($621 million) last year, marking growth of 47%, and a new approval in stomach cancer should add a further boost to its already robust growth.
