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Xeloda® in combination with oxaliplatin filed in Europe for the adjuvant treatment of patients with early colon cancer.
Basel, 4 January 2010
Label extension provides a new option to enable more patients to live disease-free for longer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has submitted an application to the European Medicines Agency (EMEA) to extend the label of Xeloda (capecitabine) for use in combination with oxaliplatin (XELOX) in the adjuvant (post-surgery) treatment of patients with early colon cancer. The filing is based on results from the pivotal NO16968 (XELOXA) study, the largest-ever study of patients with stage III (early) colon cancer, which showed that patients taking XELOX immediately after surgery lived disease-free for longer compared to those treated with commonly used chemotherapy regimen 5-fluorouracil/leucovorin (5-FU/LV).1 The 3 year disease-free survival (DFS) for patients receiving XELOX was significantly superior to the 5-FU/LV arm (70.9% versus 66.5%, HR 0.80, p=0.0045). The DFS result obtained with XELOX is similar to that shown in trials evaluating the use of FOLFOX (oxaliplatin in combination with infusional 5FU/LV) in patients with stage III colon cancer.
The study also showed that XELOX offered patients significantly superior relapse-free survival (RFS) at 3, 4 and 5 years compared to treatment with 5-FU/LV (HR=0.78, p=0.0024). Overall survival data from the study are currently immature, but show a trend towards superiority for XELOX at 5 years (77.6% versus 74.2%, HR=0.87, p=0.1486). Follow-up is ongoing and results will be reported when available.
Xeloda as monotherapy is already licensed for adjuvant treatment of colon cancer throughout the world including Europe, the US and Japan.
"Xeloda monotherapy is proven to be highly effective in the treatment of colon cancer, and recent studies have shown that the addition of oxaliplatin further improves patient outcomes. When treated promptly, early colon cancer can be considered a curable disease, and the use of XELOX can help more patients live disease-free," said William M. Burns, CEO of Roche’s Pharmaceuticals Division.
Colorectal cancer is the second most common cause of death from cancer across all tumour types in Europe2 and is the third most commonly reported cancer in the world.3
About the NO16968 study
The NO16968 trial (XELOXA) is a randomised, phase III study of XELOX (oral Xeloda in combination with intravenous oxaliplatin) versus 5-FU/LV as adjuvant therapy for patients with stage III colon cancer who have undergone surgery. The study included 1886 patients and was conducted at 226 study sites across 29 countries. The primary endpoint of the study was to assess the superiority of XELOX versus 5-FU/LV in terms of 3 year DFS. Secondary endpoints included overall survival, RFS, safety profiles and perceived treatment convenience between the treatment arms. The trial demonstrated that XELOX offered significantly superior disease-free survival (DFS) at three, four and five years.
Significantly superior DFS for XELOX was observed at three, four and five years
| |
3-year DFS |
4-year DFS |
5-year DFS |
| XELOX |
71.0% |
68.4% |
66.0% |
| 5-FU/LV |
67% |
62.3% |
60.0% |
(HR 0.80, p=0.0045)
Significantly superior RFS was also observed at three, four and five years (excludes all non-cancer-related mortality)
| |
3-year RFS |
4-year RFS |
5-year RFS |
| XELOX |
72.1% |
69.7% |
67.8% |
| 5-FU/LV |
67.5% |
63.3% |
60.9% |
(HR=0.78, p=0.0024).
About Xeloda (capecitabine)
Xeloda (capecitabine) is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs. Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital or clinic visits.
Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has over 11 years proven clinical experience providing an effective and flexible treatment option to over 1.8 million people with cancer. Xeloda is currently approved in:
Metastatic Colorectal Cancer
- Monotherapy first-line (US , EU and ROW) - 2001
- In combination with any chemotherapy in all lines of treatment with or without Avastin (EU/RoW) - 2008
- In combination with oxaliplatin for the treatment of patients with advanced or refractory colorectal cancer who are not candidates for curative surgery (Japan) - 2009
Adjuvant Colon Cancer
- Monotherapy (US & EU) - 2005
- Monotherapy (Japan) - 2007
Advanced Gastric Cancer
- First-line treatment (South Korea) - 2002
- In combination with platinum-based chemotherapy first-line (EU and ROW) - 2007
Metastatic Breast Cancer
- Monotherapy first-line in patients with tumours resistant to taxanes and anthracyclines - (US) 1998 and (EU) 2002
- In combination with docetaxel in patients whose disease has progressed following iv chemotherapy with anthracyclines - (US) 2001 and (EU) 2002
- In patients with inoperable or recurrent breast cancer - (Japan) 2003
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information, please visit: www.roche.com.
All trademarks used or mentioned in this release are protected by law.
1) Haller D et al. European Journal of Cancer Supplements, Vol. 7, No 3, September 2009, Page 4 (abstract 5LBA)
2) Ferlay J et al. Ann Oncol 2007; 18:581-92
3) Parkin DM et al. CA cancer J Clin 2005; 55:74-108 |
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