EU Clears Avastin as Combo Therapy for Recurrent Ovarian Cancer
Oct. 31, 2012
The European Commission approved Roche’s - Avastin - (bevacizumab) in combination with standard carboplatin and gemcitabine chemotherapy as a treatment for first recurrence of platinum-sensitive ovarian cancer. The anti-VEGF antibody was approved in Europe in December 2011 as post-surgery front-line treatment for women with newly diagnosed advanced ovarian cancer.
Clearance for the new indication was based on data from the Phase III Oceans study, which demonstrated that women with recurrent, platinum-sensitive ovarian cancer who received the Avastin-chemotherapy combination demonstrated significantly longer progression-free survival.
Avastin is currently approved in the U.S. for treating colorectal cancer, non-small cell lung cancer, kidney cancer, and glioblastoma. In the EU the antibody is approved for the treatment of advanced breast cancer, non-small cell lung cancer, kidney cancer, and ovarian cancer. Despite the fact that Avastin’s marketing authorization for the breast cancer indication was revoked by FDA in 2011, Roche noted in its recent third-quarter 2012 results that use of the drug as a treatment for breast cancer continues to grow in other licensed countries. The firm reported Avastin sales of CHF 4.3 billion (about $4.6 billion) in Q3 2012, up 6% on the equivalent period in 2011.