Roche’s Avastin could be approved in Europe for advanced ovarian cancer next year after another clinical trial confirmed its ability to slow down tumour growth in patients with the disease.
Following a positive study in the US, the UK-led ICON7 trial showed a 21% lower risk of disease progression in treatment-naïve ovarian cancer patients given a regimen of Avastin (bevacizumab) and standard chemotherapy followed by Roche’s drug alone, compared to those given just chemotherapy.
Furthermore, the results also showed that women who took Avastin in addition to standard chemotherapy lived for 18.3 months without disease progression compared to 16 months for those given chemotherapy alone.
Similar findings were reported from a US trial earlier this year, which showed that a higher dose of the drug was associated with a 29% cut in the risk of progression in women with advanced-stage ovarian cancer (the UK trial also included patients with high-risk early stages of the disease).
On the back of these findings, Roche is preparing to submit a licence application to the European Medicines Agency by the end of the year and anticipates a decision from the regulator in the later stages of 2011, it said.
The news marks a small turnaround in Avastin’s fortunes, which has been hit with a stream of bad news of late.
In September, Roche suffered a blow after its oncology blockbuster had failed in another late-stage trial as a potential treatment for colon cancer, while its future as a treatment for advanced HER2-negative breast cancer remains in doubt in the US as regulators consider whether to revoke its licence for this indication.
Avastin was granted accelerated approval for breast cancer in 2008 on the back of studies that showed it halted disease progression for more than five months. However, two subsequent trials have failed to show any benefit and, in July, an advisory panel voted 12 to 1 in favour of withdrawing its approval in this setting. A final decision is expected in December.