The FINANCIAL — Roche announced on July 20 results from the international phase III study NO16968 (XELOXA), investigating oral Xeloda in combination with intravenous oxaliplatin (XELOX) immediately after surgery, which show that patients with colon cancer taking XELOX live disease free for longer compared to those taking the commonly used intravenous chemotherapy combination 5-fluorouracil/leucovorin (5-FU/LV).
The data prove that XELOX is superior to 5-FU/LV in terms of the time patients live without their cancer being detectable.
The trial, conducted in previously untreated patients who have undergone surgery for colon cancer, studied use of XELOX for 24 weeks. Patients in the XELOX group demonstrated significantly better disease-free survival compared to patients receiving 5-FU/LV.
“While Xeloda is already approved for the treatment of early-stage colon cancer as monotherapy, the results of this study mean that physicians will now be able to offer their patients Xeloda as a combination chemotherapy. This is an important development for patients as colon cancer, if caught early enough, can be cured, so physicians need a wide range of treatment options”, said William M. Burns, CEO of Roche’s Pharmaceuticals Division.
Data from the trial will be submitted for presentation at upcoming international scientific meetings. Roche plans to file the data with health authorities to extend the current label for Xeloda.
Xeloda is a highly effective oral chemotherapy drug that can be used alone, or in combination with other drugs, for the treatment of colorectal (including colon), stomach and breast cancer. It is already approved for the treatment of colon cancer after surgery in the US, EU, Japan and rest of the world.
Colorectal cancer is the second most common cause of death from cancer across all cancer types in men and women in Europe1) and is the third most commonly reported cancer in the world, with nearly one million cases occurring annually2). Colon cancer refers to cancer of the large intestine (colon), which is the lower part of the digestive system, while rectal cancer specifies cancer of the last segment of the colon. Together, they're often referred to as colorectal cancer.
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