Avastin (Bevacizumab) Granted Priority Review for Treatment of Cervical Cancer
FDA approval decision expected in October 2014
The FDA has accepted a supplemental biologics license application (sBLA) and has granted priority review for Avastin (bevacizumab, Genentech/Roche) plus chemotherapy for the treatment of women with persistent, recurrent, or metastatic cervical cancer.
A priority review status is granted to medications 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.
GOG-0240 was a National Cancer Institute-sponsored study that assessed the efficacy and safety of bevacizumab plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in 452 women with persistent, recurrent, or metastatic cervical cancer.
The study met its primary endpoint of improving overall survival (OS), with a statistically significant 29% reduction in the risk of death for women who received bevacizumab plus chemotherapy compared with those who received chemotherapy alone (median OS: 17.0 months vs. 13.3 months, respectively; hazard ratio [HR] = 0.71; P = 0.004).
Women in the bevacizumab-plus -chemotherapy arm also lived longer without disease worsening (progression free survival [PFS]) compared with those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months, respectively; HR = 0.67; P = 0.002).
Hypertension of grade 2 or higher was significantly more common with bevacizumab-containing regimens compared with chemotherapy alone (25% vs. 2%, respectively), but no patients discontinued bevacizumab because of hypertension. 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%).
Avastin (bevacizumab) is a prescription-only medication that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to the vascular endothelial growth factor (VEGF) protein, which promotes angiogenesis. The drug is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to metastasize.
In the U.S., Avastin (bevacizumab) is approved for first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-fluorouracil (5-FU)–based chemotherapy. Avastin, in combination with fluoropyrimidine–irinotecan– or fluoropyrimidine–oxaliplatin–based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen. Avastin is not indicated for adjuvant treatment of colon cancer.
Avastin is also approved for first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non–small-cell lung cancer in combination with carboplatin and paclitaxel, and of metastatic renal cell carcinoma in combination with interferon alfa.
Source: Genentech; July 14, 2014.