Investor Update

Basel, 16 December 2010

Roche provides update on Avastin for metastatic breast cancer following reviews in Europe and the United States

  • In the European Union, Avastin confirmed as a valuable treatment option in combination with paclitaxel
  • In the United States, the company will request a hearing to maintain Avastin as a treatment option for metastatic breast cancer

Roche confirmed that following the reviews of Avastin (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

EMA/European Committee for Medicinal Products for Human Use (CHMP) update:

  • The EMA has confirmed that Avastin in combination with paclitaxel has been convincingly shown to enable women with metastatic breast cancer to live longer without their disease getting worse (progression-free survival).
  • The EMA has also stated that “the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer”.
  • Paclitaxel is the chemotherapy most frequently used in Europe and also most frequently partnered with Avastin for the first-line treatment of metastatic breast cancer.
  • The CHMP, which is part of EMA, recommended the removal of the combination of Avastin with docetaxel from the label based on uncertainty about the benefit of the combination and also recommended against a label extension with capecitabine.
  • A European Commission decision on this opinion will be issued in due course.
  • The CHMP opinion does not affect the other approved uses of Avastin in the European Union for advanced colorectal, kidney and lung cancer.

U.S. FDA update:

  • The FDA notified Genentech of its “Proposal to Withdraw Marketing Approval” of Avastin for first-line treatment of metastatic HER2-negative breast cancer in combination with paclitaxel and issued a “Notice of Opportunity for a Hearing” (NOOH). An NOOH is the mechanism the FDA uses to provide a company an opportunity for hearing on a proposal to withdraw an indication.
  • Genentech will request a hearing. If the FDA grants a hearing, there is no set date for when this would occur.
  • Until the conclusion of these proceedings, Avastin remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.
  • The FDA also issued Complete Responses on AVADO and RIBBON1 for the first-line use of Avastin in combination with other chemotherapies in metastatic breast cancer and a Complete Response on RIBBON2 for the second-line use of Avastin plus chemotherapy in metastatic breast cancer.
  • The FDA’s decision does not impact Avastin’s availability for its approved uses for other cancer types in the United States.
  • “We are pleased that the EMA has confirmed the benefits of Avastin in combination with paclitaxel and that Avastin will continue to be available for women with metastatic breast cancer living within the European Union,” said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA.”

About Avastin: Over 5 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 the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and over 25 other countries for the treatment of patients with glioblastoma (a type of brain 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 three quarters of a 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 tumor types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).

Avastin contraindications and special warnings and precautions

Contraindications: hypersensitivity to the active substance or to any of the excipients, hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanised antibodies, pregnancy.

Special warnings and precautions for use: gastrointestinal perforations, fistulae, wound healing, hypertension, reversible posterior, leukoencephalopathy syndrome, proteinuria, arterial thromboembolism, venous thromboembolism, haemorrhage congestive heart failure, neutropenia and infections, hypersensitivity reactions/infusion reactions, osteonecrosis of the jaw, eye disorders.

About Avastin: Mode of Action

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis – a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.

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 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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:

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