A STEP CLOSER FOR AVASTIN APPROVAL IN OVARIAN CANCER BY EMA

CHMP issues opinion on new indication for Avastin

Last updated: 28 Sep 2011

The EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the use of Roche's Avastin(R) (bevacizumab) in combination with standard chemotherapy (carboplatin and paclitaxel) as a front-line treatment for women with advanced ovarian cancer. Specifically, the committee has recommended the use of the drug in combination with standard chemotherapy in the front-line treatment of advanced (International Federation of Gynecology and Obstetrics [FIGO] stages IIIB, IIIC and IV) epithelial ovarian, primary peritoneal or fallopian tube carcinoma. The opinion is supported by the phase III studies GOG-0218 and ICON-7, in which women who received the combination of bevacizumab and chemotherapy and then continued on bevacizumab alone experienced significantly improved progression-free survival compared with those receiving only chemotherapy (respective ClinicalTrials.gov Identifiers NCT00262847 and NCT00483782; see Thomson Reuters Drug News, February 26 2010 and July 5, 2010). Bevacizumab also demonstrated significant improvement in a recurrent, platinum-sensitive setting of the phase III study OCEANS (a study Of Carboplatin and gEmcitabine plus bevAcizumab in patieNtS with ovary, peritoneal, or fallopian tube carcinoma; ClinicalTrials.gov Identifier NCT00434642; see Thomson Reuters Drug News, February 8, 2011). The product is administered in six treatment cycles, followed by its continued use as monotherapy, until disease progression or for a maximum of 15 months. The recommended dose is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. Bevacizumab is an antibody that specifically binds and blocks the biological effects of vascular endothelial growth factor (VEGF). First approved in the U.S. for the treatment of advanced colorectal cancer in 2004, it has since gained approval in the U.S. and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. It is also available in the U.S. and in over 32 other countries for the treatment of patients with glioblastoma. Currently, the clinical program for bevacizumab includes more than 500 ongoing trials in 50 tumor types, including colorectal, breast, non-small cell lung, brain, gastric, ovarian and other cancers, in both early and advanced settings