The study showed that women who were treated with a combination of Avastin and chemotherapy (carboplatin and gemcitabine), followed by continued use of Avastin alone until disease progression, lived longer without their disease worsening (progression-free survival or PFS), compared to women who were treated with chemotherapy alone.
No new safety findings were seen and adverse events were consistent with those seen in previous pivotal trials of Avastin.
The results from this study build on findings from two previous Phase III studies (GOG 0218 and ICON7) in women with newly diagnosed ovarian cancer,
The two studies showed that front-line Avastin in combination with standard chemotherapy, followed by the continued use of Avastin alone, significantly increased progression-free survival, compared to those treated with chemotherapy alone.
Based on the results from GOG 0218 and ICON7, Roche has submitted a European Union marketing authorisation application for the use of Avastin in the front-line setting and expects a decision from the Committee for Medicinal Products for Human Use (CHMP) later this year.
Genentech plans to submit applications in the US for the use of Avastin in ovarian cancer in 2011.