Media Release

Basel, 16. November 2012

Roche receives positive opinion from European Medicines Agency for Avastin based treatment beyond first progression in people with advanced colorectal cancer

The continued use of Avastin based therapy beyond first progression in metastatic colorectal cancer patients leads to survival benefits

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for the addition of data from the ML18147 study to the current European label of Avastin® (bevacizumab). This will allow people diagnosed with metastatic colorectal cancer who receive Avastin plus chemotherapy as a first line treatment to continue to receive Avastin plus chemotherapy after their cancer worsens as a second line treatment.

The ML18147 study, the basis of the application, demonstrated that people with metastatic colorectal cancer who were initially treated with Avastin, lived longer when they continued on Avastin-based therapy after their disease had progressed for the first time, than those who received only chemotherapy after disease progression. The results from ML18147 were first presented at ASCO 2012 (abstract #CRA3503). Continuing Avastin-based therapy had minimal additional impact on frequency of adverse events and the adverse event profile for Avastin in this study was consistent with previous studies in colorectal cancer.

"People with metastatic colorectal cancer who continued Avastin treatment with a new chemotherapy regimen after their cancer worsened lived longer than patients who changed to a new chemotherapy only,” said Hal Barron M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This positive CHMP opinion is an important step towards potentially changing the approach to treatment of metastatic colorectal cancer and providing a new option for patients.”

Avastin is the only biological therapy proven to increase overall survival when used first-line, beyond first progression, and in second-line treatment of metastatic colorectal cancer.

Colorectal cancer is one of the most common cancers in the world, with over 1.2 million new cases diagnosed each year and it remains one of the biggest cancer killers in the world responsible for over 600,000 deaths globally each year1.

About the ML18147 study

ML18147 was a randomised, open-label phase III multicentre, multinational trial evaluating the efficacy and safety profile of Avastin plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following Avastin plus standard first-line chemotherapy (irinotecan or oxaliplatin-based). Patients were randomised at progression to one of two treatment arms:

  • Arm A: Chemotherapy* plus Avastin (equivalent of 2.5 mg/kg i.v. per week)
  • Arm B: Chemotherapy* alone
    *Depending on the first-line chemotherapy backbone (fluoropyrimidine / irinotecan-based or fluoropyrimidine / oxaliplatin-based) the chemotherapy backbone was switched in the second-line setting.

The primary endpoint of the study was overall survival measured from the time patients were randomised to the second-line treatment. The secondary efficacy endpoints of the study included PFS, overall response rate and safety profile.

About Avastin: Over 8 Years of Transforming Cancer Care

With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the US and over 30 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer and breast cancer. Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today – over one million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

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 personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 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: www.roche.com.

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References:
1.WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008 athttp://globocan.iarc.fr/