The sBLA for Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) is based on data from the phase III GOG-0240 trial with an FDA action date of 24 October 2014.
Roche head of Global Product Development 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," Horning said.
The phase III trial (GOG-0240) has evaluated the safety and efficacy profile of Avastin plus chemotherapy in 452 women with persistent, recurrent or metastatic cervical cancer.
The company said that the trial 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.
In the US, Avastin is approved for first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.
Image: Genentech’s Avastin plus chemotherapy has been evaluated in a Phase III trial conducted in women with persistent, recurrent or metastatic cervical cancer. Photo: courtesy of Baitong333/ freedigitalphotos.net