The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy in the treatment of women with persistent, recurrent, or metastatic cervical cancer.
The designation of Priority Review status is granted to drugs 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 supplemental Biologics License Application for bevacizumab plus chemotherapy in cervical cancer is based on data from the phase III GOG-0240 trial.
GOG-0240 Study
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored phase III study assessing the efficacy and safety profile of bevacizumab plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent, or metastatic cervical cancer.
Study data from 452 women showed that the study met its primary endpoint of overall survival with a statistically significant 29% reduction in the risk of death for women who received bevacizumab plus chemotherapy vs chemotherapy alone. Median overall survival for women receiving bevacizumab plus chemotherapy was 17.0 months, compared to 13.3 months for chemotherapy alone (hazard ratio [HR] = 0.71, P = .004).
Women in the bevacizumab-plus-chemotherapy arm also lived longer without disease worsening compared to those who received chemotherapy alone, with a median progression-free survival of 8.2 months vs 5.9 months (HR = 0.67, P = .002).
Hypertension of grade 2 or higher was significantly more common with bevacizumab-containing regimens (25% vs 2%), but did not result in the discontinuation of the drug. Gastrointestinal or genitourinary fistulas of grade 3 or higher were significantly increased with the bevacizumab-containing regimens (6% vs 0%), as were thromboembolic events of grade 3 or higher (8% vs 1%).
There was no increase in treatment-related deaths in the bevacizumab-plus-chemotherapy arm, as compared to the chemotherapy-alone arm. ■
