Roche announced the successful conclusion of a large international phase III study comparing Xeloda with standard intravenous 5-FU/LV in the adjuvant treatment of early stage colon cancer. Oral Xeloda was proven to be at least equivalent to intravenous 5-FU/LV, meeting the primary end-point of the trial.
Professor Jim Cassidy (University of Glasgow, UK) has submitted the data of this phase III trial for presentation at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans in June.
William M. Burns, Head of Roche's Pharmaceuticals Division said, "We believe that the new Xeloda data will be important to patients treated for early stage colon cancer, and Roche will submit the study results to global regulatory authorities. Adjuvant therapy is a significant new opportunity for Xeloda, which will further strengthen the Roche oncology portfolio."
In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50 per cent of people diagnosed with colorectal cancer will die of the disease, and it is one of the most common cancers in developed countries.
Within the last five years the Roche Group has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin which has been launched in the US recently, treat a range of malignancies such as breast cancer, non-Hodgkin's lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche's cancer medicines generated sales of more than 6 billion Swiss francs in 2003.
In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer.
Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).