The European Commission has extended the existing bevacizumab (Avastin?, Roche/Genentech) metastatic breast cancer label to include combination with capecitabine (Xeloda?, Roche/Genentech). The European Commission had recently confirmed the approval of bevacizumab in combination with paclitaxel chemotherapy for women with metastatic breast cancer in the first-line setting. This new extension provides an additional first-line treatment option for women in whom treatment with other chemotherapies (including taxanes or anthracyclines) is not considered appropriate.

Bevacizumab 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. The drug’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. The drug helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.

European label extension
The label extension was based on data from the phase III RIBBON 1 study which showed a significant increase in the length of time women lived without their disease getting worse (progression-free survival) when bevacizumab was combined with capecitabine, a highly effective targeted oral chemotherapy which activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells, compared to those who received capecitabine alone. Adverse events in RIBBON 1 were consistent with those seen in previous pivotal trials of bevacizumab across tumor types.

?The decision received from the EU Commission supports our belief that Avastin provides a clinically meaningful benefit in combination with Xeloda,? said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. ?We are pleased with this outcome because it means that women with metastatic breast cancer and their physicians will now have an additional treatment option in Europe.?

Study results
Data from the pivotal E2100 (Avastin and paclitaxel) study forms the basis of bevacizumab?s licensed combination with paclitaxel in metastatic breast cancer. This showed that bevacizumab in combination with paclitaxel chemotherapy doubled median progression-free survival (PFS) compared with paclitaxel alone. Some chemotherapy options including taxanes and anthracyclines are not always appropriate for all women with metastatic breast cancer. The approval of this broader label will give these women an additional first-line therapy choice.

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RIBBON 1 trial
Results from the RIBBON 1 study of bevacizumab in combination with capecitabine showed a 45% increase in the likelihood of women being alive without disease progression compared to those who received capecitabine alone (hazard ratio=0.69; p=0.0002). A median PFS of 8.6 months compared to 5.7 months in those women that received capecitabine alone. 35.4% of women experienced a major shrinkage of their tumor compared to 23.6% of those receiving capecitabine alone (p= 0.0097).

Transforming cancer care
With the initial approval in the USA for advanced colorectal cancer in 2004, bevacizumab became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer. Today, bevacizumab is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer including breast cancer, non-small cell lung cancer and kidney cancer. The drug is also available for the treatment of patients with glioblastoma

Fundamental pillar of cancer treatment
Bevacizumab has made anti-angiogenic therapy a fundamental pillar of cancer treatment today ? over one million patients have been treated with bevacizumab so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of bevacizumab 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).

For more information:
– European Post-authorisation summary of positive opinion..

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