Avastin approved in Europe for first-line treatment of patients with advanced lung cancer

RocheAvastin (bevacizumab), Roche's innovative anti-cancer drug, was approved today in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

NSCLC is the most common form of lung cancer, a difficult to treat disease that kills over 3,000 people per day worldwide[1]. NSCLC is usually diagnosed at an advanced stage, meaning individuals diagnosed with the disease typically have a life expectancy of only 8 to 10 months[2,3]. Avastin is the only first-line therapy to demonstrate improved survival benefits beyond one year in patients with advanced NSCLC.

"Today's approval represents a massive breakthrough for the treatment of individuals with advanced lung cancer," said William M. Burns, CEO of Roche's Pharmaceuticals Division. "We will continue to work with European authorities to make Avastin available to as many patients with NSCLC as possible."

The approval is based on data from the pivotal US phase III trial (E4599) and the 'Avastin in Lung' (AVAiL) phase III trial. Both studies demonstrate that Avastin is effective for the treatment of patients with NSCLC in combination with platinum-based chemotherapy. The approval is for the use of Avastin at a dose of 7.5 or 15 mg/kg, in combination with platinum-based chemotherapy, for the first-line treatment of patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology. The broad label that Avastin has received for the treatment of NSCLC allows the combination of Avastin with any platinum-based chemotherapy regimens (for example, together with taxanes or gemcitabine) at the choice of the physician.

Professor Christian Manegold, Professor of Medicine at Heidelberg University, University Medical Center Mannheim, Germany and Principal Investigator of the AVAiL trial, was enthusiastic about the news: "Lung cancer is an extremely difficult disease to treat and Avastin has proven that it can prolong the life of patients with NSCLC. A treatment like Avastin that breaks through the one year survival barrier is a big step forward. The European approval for Avastin means we can reassess our expectations for lung cancer patient survival."

Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival for patients with colorectal, lung, breast and kidney cancer.

About the Phase III studies that formed the basis of the approval
E4599 study
The results of the randomised, controlled, multicentre phase III E4599 study of 878 patients with locally advanced, metastatic or recurrent NSCLC, with histology other than predominant squamous cell, show that median survival of patients treated with Avastin at a dose of 15 mg/kg every three weeks plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. Patients receiving Avastin in combination with paclitaxel and carboplatin had a 25% improvement in overall survival compared to patients who received chemotherapy alone. Side effects were generally manageable. Pulmonary haemorrhage/ haemoptysis cases were observed in 2.3% of the patients receiving Avastin plus chemotherapy. The most common adverse events associated with Avastin therapy were: hypertension (5.6%), proteinuria (4.2%), fatigue (5.1%) and dyspnoea (5.6%).[4]

AVAiL study
In the double-blind, randomised, controlled, phase III AVAiL study, patients received treatment with either Avastin at 7.5mg/kg or 15mg/kg + cisplatin/gemcitabine or placebo + cisplatin/gemcitabine. The study involved more than 1,000 patients world-wide with previously untreated advanced NSCLC, with histology other than predominant squamous cell. The results show that by adding Avastin to a cisplatin/gemcitabine regimen progression-free survival was significantly prolonged by 20 to 30% compared with chemotherapy alone. No new or unexpected adverse events were observed.

About Lung Cancer
According to the World Health Organization (WHO), lung cancer is the leading cause of cancer-related deaths in both men and women, [5] responsible for 19.7% of all cancer deaths.[6] Lung cancer is the single biggest cancer killer in Europe, claiming 334,800 lives in 2006.[6] World-wide, there are more than 1.2 million new cases of lung and bronchial cancer diagnosed each year,[5] and new treatment options are urgently needed as the disease has a very high mortality rate.

NSCLC is the most common form of the disease and accounts for more than 80% of all lung cancers.[7] The majority of NSCLC cases are still diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than 5% of people with advanced NSCLC survive for 5 years after diagnosis, and most patients with metastases to other organs die within 6 months.[7]

About Avastin
Avastin is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

In Europe, Avastin was approved in January 2005 and in the US in February 2004 for first-line treatment of patients with metastatic colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. The world's first angiogenesis inhibitor was approved by the FDA for the treatment of NSCLC in October 2006, following priority review. Most recently in March 2007, Avastin was approved in Europe for the first-line treatment of women with metastatic breast cancer and in April in Japan for use in advanced or recurrent colorectal cancer.

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma, and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.

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 75,000 people. Additional information is available on the Internet at www.roche.com.

References
1. Kamangar F, et al. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 2006; 24(14): 2137-50.
2. Schiller JH, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002;346:92-8.
3. Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. N Engl J Med. 2006:355; 2542-50
4. Data on file. Roche, 2006
5. Stewart BW and Kleihues P. World Cancer Report. IARC Press, Lyon, pp.183-7, 2003
6. Ferlay J, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology. 2007; 18: 581-92.
7. Wilking N and Jonsson B. A Pan-European comparison regarding patient access to cancer drugs. Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden, 2005.

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