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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.