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Investor Update

Basel 4 February 2008

EU Grants Broad Approval of Xeloda for Patients with Metastatic Colorectal Cancer
Many more patients can now benefit from oral chemotherapy that significantly reduces treatment time

Roche announced today that the European Commission has approved its oral chemotherapy Xeloda (capecitabine) for the treatment of metastatic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin.  This broad approval means that more patients suffering from colorectal cancer that has spread will now be able to take advantage of effective and innovative treatments with proven patient benefits.

Approval was based on the pivotal studies demonstrating:

  • Xeloda tablets provide patients with a more flexible treatment option with less hospital treatment time, whilst continuing to deliver the same survival benefits and safety as the previous standard chemotherapy intravenous (iv) 5-FU.
  • Avastin in combination with chemotherapy allows patients to live significantly longer without their cancer progressing.

“Colorectal cancer is a devastating disease and treatment options for patients have been limited,” said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. “Until now, Xeloda has been available to only a few colorectal cancer patients. But several studies have now shown that almost all patients with colorectal cancer that has spread can benefit from Xeloda at any time and in combination with any chemotherapy treatment.  It is a highly effective oral chemotherapy that reduces hospital treatment time by 160 hours compared to the old standard chemotherapy, allowing patients to live as normal a life as possible.”

“This approval shows that the EU authorities have endorsed that oral Xeloda can replace iv 5-FU in all colorectal cancer regimens, making cancer treatment regimens easier for patients,” Professor Cassidy concluded.  

It is estimated that more than 400,000 people in Europe will be diagnosed with metastatic colorectal cancer every year. 1  The previous standard treatment, iv 5-FU was particularly burdensome on patients.  Now oral Xeloda offers a better alternative that can be used alone or in combination with oxaliplatin or irinotecan to provide a therapy that is highly effective, safe and flexible.  

Data submitted to the regulatory authorities that contributed to the broad approval included pivotal studies on XELOX (Xeloda with oxaliplatin) with or without Avastin and supporting studies on XELIRI (Xeloda in combination with irinotecan) with or without Avastin. 2,3  

Notes to editors:
About the Phase III studies that formed the basis of the approval

NO16966
NO16966 is a large, international Phase III trial which recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer. After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate using a 2 by 2 factorial design:  FOLFOX/XELOX + placebo vs FOLFOX/XELOX + Avastin.

The primary objective was to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone.  The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.
Results of the study showed:

  • The chemotherapy combination XELOX is as effective in terms of progression-free survival– a measure of the time patients live without their disease progressing – as FOLFOX;^
  • The addition of Avastin to chemotherapy (FOLFOX and XELOX) significantly improved progression-free survival compared to chemotherapy alone.

NO16967
The NO16967 trial is a large, international phase III trial which randomized 627 patients from 15 countries world-wide who had previously received irinotecan-containing combination chemotherapy and whose disease had returned or continued to progress. The primary objective was to answer whether the XELOX regimen (Xeloda plus oxaliplatin) is as effective as FOLFOX-4 (i.v. bolus and infusional 5-FU/leucovorin plus oxaliplatin) in terms of progression-free survival. The secondary outcomes to be reviewed included overall survival, overall response rates, and safety profile. The results showed:

  • The chemotherapy combination XELOX is as effective in terms of progression-free survival as the chemotherapy combination FOLFOX.  

About Xeloda
Xeloda is licensed in more than 100 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be an effective, safe, and convenient oral chemotherapy in treating over 1.5 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001.  Xeloda has also been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following i.v. chemotherapy with anthracyclines.  Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines.  Xeloda received approval in South Korea for the first-line treatment of patients with locally advanced (metastatic) pancreatic cancer, in combination with gemcitabine.  Xeloda is licensed in South Korea for the first-line treatment of stomach cancer, and has recently received EU approval for the first-line treatment of advanced stomach cancer in combination with a platinum agent. In Japan it is licensed in post-surgery colon cancer and advanced breast cancer.  

The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia).

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 78,000 people. Additional information is available on the Internet at www.roche.com.


1. Ferlay J, AutierP et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology 18: 581–592, 2007.
2. CAIRO Phase III Study Koopman et al. Lancet 2007
3. AIO Study Schmiegel et al. ASCO 2007 (Abst 4034)