The US Food and Drug Administration (FDA) has accepted Roche subsidiary Genentech’s supplemental biologics licence application (sBLA) and granted priority review for Avastin plus chemotherapy for treatment of women with persistent, recurrent or metastatic cervical cancer.
Priority review designation for Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) has been granted by the FDA based on data from the Phase III GOG-0240 trial. The FDA action date is 24 October 2014.
Roche global product development head and chief medical officer Sandra Horning said: "This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer.
"Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients."
The Phase III GOG-0240 trial has evaluated the safety and efficacy profile of Avastin plus chemotherapy in 452 women with persistent, recurrent or metastatic cervical cancer.
The study met its primary endpoint of improving overall survival with a statistically significant 29% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone.
By directly binding to the vascular endothelial growth factor protein, Avastin interferes with the tumour blood supply and prevents interactions with receptors on blood vessel cells.
Image: Cervical cancer seen on a T2 weighted saggital MR image of the pelvis. Photo: courtesy of Radiolog.