ZURICH (Reuters) - Roche said on Wednesday that the European Commission approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy in women with recurrent ovarian cancer resistant to platinum-containing chemotherapy.
The approval was based on results of the phase 3 AURELIA study which involved women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin in combination with chemotherapy.
Results showed that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression free survival (PFS) from 3.4 months to 6.7 months (HR=0.38, p<0 .0001="" a="" in="" p="" roche="" said="" statement.="">
AURELIA is the fourth phase 3 study of Avastin in ovarian cancer to show that adding Avastin to chemotherapy significantly increased PFS.
Avastin is also approved in Europe as a front-line treatment for advanced ovarian cancer and for recurrent, platinum-sensitive ovarian cancer, as well as for advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer and kidney cancer.
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