CHMP recommends label expansion for Avastin

The EU Committee for Medicinal Products for Human Use recommends that the European Commission approve the use of Roche's (RHHBY) Avastin (bevacizumab) in combination with chemotherapy as a treatment for women with platinum-resistant ovarian cancer. Avastin is currently EU-approved as a front-line (first line after surgery) treatment of advanced ovarian cancer and as a treatment for recurrent platinum-sensitive ovarian cancer.

Ovarian cancer is associated with high concentrations of vascular endothelial growth factor ((VEGF)), a protein linked to tumor growth and spread. Avastin is designed to specifically target VEGF. It is the only targeted therapy approved by the European Medicines Agency (EMA) for ovarian cancer.

Roche's filing is based on the results from the Phase 3 AURELIA study. Patients receiving the Avastin/chemo combination demonstrated a statistically significant improvement in progression-free survival (PFS) from 3.4 months to 6.7 months and a significantly higher rate of tumor shrinkage.

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