Avastin gets FDA Priority Review for advanced cervical cancers
Avastin has been granted an FDA priority review for the treatment of women with persistent, recurrent or metastatic cervical cancer.
Genentech's Avastin (bevacizumab) combined with chemotherapy could help advance treatment significantly in this group of patients, after phase III trials showed promising results.
"This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer," said Dr Sandra Horning, chief medical officer and head of Global Product Development at Genentech, part of the Roche group. "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."
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'. This sBLA is based on data from the phase III GOG-0240 trial with an FDA action date of 24 October 2014.
The study
GOG-0240 was an independent, National Cancer Institute-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 per cent 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 per cent vs. 2 per cent), but no patients discontinued Avastin because of hypertension. Gastrointestinal or genitourinary fistulas of Grade 3 or higher were significantly increased with the Avastin-containing regimens (6 per cent vs. 0 per cent), as were thromboembolic events (blood clots) of Grade 3 or higher (8 per cent vs. 1 per cent).
There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.
There is a dramatic difference in survival rates between early and advanced cervical cancer. At least nine out of 10 women will live for five years following diagnosis of early stage disease but the survival rate drops to below one in six women when the disease is metastatic.
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