Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer. “This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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 designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastatic cervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.
About the GOG-0240 study
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored Phase III study which assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent, or metastatic cervical cancer. Study data from 452 women showed:
• The study met its primary endpoint of improving overall survival (OS) with a statistically significant 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 17.0 months vs. 13.3 months; Hazard Ratio (HR)=0.71, p=0.004).
• Women in the Avastin plus chemotherapy arm also lived longer without disease worsening (progression free survival, PFS) compared to those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, p=0.002).
• Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (25 percent vs. 2 percent), but no patients discontinued Avastin because of hypertension. Gastrointestinal or genitourinary fistulas (abnormal passage from one part of the body to another) of Grade 3 or higher were significantly increased with the Avastin-containing regimens (6 percent vs. 0 percent), as were thromboembolic events (blood clots) of Grade 3 or higher (8 percent vs. 1 percent). There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.