The Committee for Medicinal Products for Human Use(CHMP) has adopted a positive opinion for an extension to the bevacizumab (Avastin?, Roche/Genentech) breast cancer label in Europe. The application proposed the use of bevacizumab in combination with capecitabine (Xeloda?, Roche/Genentech)for the first-line treatment of women with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes and anthracyclines is not considered appropriate. Bevacizumab is already approved in Europe in combination with paclitaxel chemotherapy in this setting.
The combination of bevacizumab with paclitaxel or capecitabine, offeres more choice to physicians and patients.
The submission to expand the label was based on results 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 compared to those who received capecitabine alone.
The current EU bevacizumab licence for metastatic breast cancer is for combination use with paclitaxel chemotherapy. However taxane-based chemotherapy is not suitable for all patients. The RIBBON 1 study showed that bevacizumab in combination with capecitabine could give these women an additional first-line therapy choice. Final approval from the European Commission is expected later this year.
?We are pleased the CHMP has determined that Avastin in combination with capecitabine provides a meaningful clinical benefit in metastatic breast cancer, affording physicians and patients more choice in selecting an appropriate treatment option,? said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. ?Avastin is the only anti-angiogenic therapy approved to treat HER2-negative metastatic breast cancer in Europe and the capecitabine data from the RIBBON 1 study, which was the basis of this positive opinion, add to the clinical evidence supporting the use of Avastin as a treatment for this disease?.
RIBBON 1 showed that bevacizumab in combination with capecitabine resulted in 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).
The Study also showed a median PFS of 8.6 months compared to 5.7 months in those women that received capecitabine alone. Furthermore, 35.4% of women experiencing a major shrinkage of their tumour compared to 23.6% of those receiving capecitabine alone (p= 0.0097). RIBBON 1 adds to the existing clinical evidence demonstrating the benefits of Avastin in metastatic breast cancer. The pivotal E2100 (bevacizumab and paclitaxel) study forms the basis of the currently approved EU label allowing combination of bevacizumab with paclitaxel to treat women with metastatic breast cancer.
Fundamental in Cancer Treatment
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.
Bevacizumab has made anti-angiogenic therapy a fundamental pillar of cancer treatment today ? over three quarters of a 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).