The European Commission approved Roche's Avastin (bevacizumab) in combination with standard chemotherapy for the treatment of adults with persistent, recurrent or metastatic carcinoma of the cervix, the company announced Wednesday. Roche's chief medical officer Sandra Horning remarked "we are pleased that women in Europe now have a much needed new treatment option that is proven to help them live longer lives compared to chemotherapy alone."
According to the drugmaker, the clearance was based on data from the GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26 percent reduction in the risk of death, representing a median improvement in survival of nearly 4 months, compared to women who received chemotherapy alone. In the trial, median overall survival for women who received Avastin was 16.8 months compared to 12.9 months for those given chemotherapy alone.
Last year, Avastin was approved in the US and Switzerland based on results from the GOG-0240 study for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
In Europe, Avastin is also authorised for the treatment of advanced stages of breast cancer, colorectal cancer, non-small-cell lung cancer, kidney cancer and ovarian cancer.
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