The EC approved Roche’s Avastin in combination with standard carboplatin and paclitaxel chemotherapy as first-line, postsurgery treatment for women with advanced (FIGO stages IIIB, IIIC, and IV) epithelial ovarian, primary peritoneal, or fallopian tube cancer. Clearance of the drug in Europe for this indication was based on data from two Phase III studies, GOG0218 and ICON7, which demonstrated that women treated using Avastin plus chemotherapy, and then Avastin monotherapy, had significantly longer progression-free survival than those treated using chemotherapy alone.
“Today’s approval of Avastin marks the first major treatment advance in newly diagnosed ovarian cancer in 15 years,” comments Hal Barron M.D., CMO and head of global product development at Roche. “This is the fifth tumor type for which Avastin has been approved in Europe, making it one of few biologic drugs indicated for multiple cancers."
Last month FDA revoked Avastin’s approval, originally granted in 2008, for use of the drug in combination with paclitaxel in the treatment of women with Her2-negative metastatic breast cancer, after its review concluded that the drug had not been shown to be safe and effective for that use.
Earlier this year the European regulators concluded that Avastin could continue to be used in combination with paclitaxel and capecitabine for treating metastatic breast cancer. However, the EC did withdraw the combination of Avastin with docetaxel for treating the disease.
Avastin is currently approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small-cell lung cancer, and kidney cancer and is also cleared in the U.S. for the treatment of colorectal cancer, non-small-cell lung cancer, and kidney cancer.
The drug is in addition is approved in the U.S. and over 30 other countries for the treatment of patients with glioblastoma and has been sanctioned in Japan for the treatment of inoperable or recurrent breast cancer.