Regulators in the USA have granted a priority review to Roche’s blockbuster Avastin in another indication, this time for cervical cancer.
Specifically, the US Food and Drug Administration has accepted the company’s supplemental Biologics License Application and granted priority review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer. This means that the Prescription Drug User Fee Act (PDUFA) date is October 24.
The filing is based on a 452-patient Phase III trial which showed that Avastin improved overall survival with a statistically significant 29% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those on chemo alone (median OS: 17.0 months versus 13.3 months). They also lived longer without disease worsening, i.e. progression free survival of 8.2 months vs 5.9 months.
Sandra Horning, Roche’s chief medical officer, said that this regulatory application for Avastin is important “because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer”. The drug is already approved in the USA for a variety of cancers, notably colorectal, lung and kidney.
In March, NHS England added Avastin to the country’s Cancer Drugs Fund for dvanced cervical cancer.
