The U.S. Food and Drug Administration (FDA) approved antiangiogenic agent bevacizumab (Avastin®) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. The approval was based on results from the Phase III AURELIA study that showed Avastin plus chemotherapy reduced the risk of disease worsening or death (progression-free survival or PFS) by 62 percent compared to women who received chemotherapy alone (median PFS: 6.8 vs. 3.4 months, Hazard Ratio (HR)=0.38; p<0.0001). Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications, but also included high blood pressure and pain, redness or swelling of the hands or feet from the Phase III study.
The new indication of Avastin is in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens. With this approval, Avastin is approved in the United States to treat six distinct tumor types.
About the AURELIA Study
AURELIA is a company-sponsored, multicenter, randomized, open-label, Phase III study in 361 women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer, who had received no more than two anticancer regimens prior to enrollment in the trial. Participants were randomized to one of six treatment arms (paclitaxel, topotecan or pegylated liposomal doxorubicin with or without Avastin). The primary endpoint of the study was investigator-assessed PFS.
About Ovarian Cancer
Ovarian cancer causes more deaths than any other gynecologic cancer in the United States. In 2014, nearly 22,000 women will be diagnosed with ovarian cancer in the United States and more than 14,000 will die from the disease. Patients are said to have ‘platinum-resistant’ disease if the disease worsens within six months of completing platinum-based chemotherapy. One quarter of those who relapse after initial treatment, more than 4,300 women, will have platinum-resistant cancer, the most difficult-to-treat form of the disease.
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin 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 grow and spread in the body (metastasize).
Avastin U.S. Indications:
Avastin is approved for the first or second line treatment of patients with metastatic colorectal cancer in combination with intravenous 5 fluorouracil–based chemotherapy. Avastin in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is approved for the second line treatment of patients with metastatic colorectal cancer who have progressed on a first line Avastin-containing regimen. Avastin is not approved for adjuvant treatment of colon cancer.
Avastin, in combination with carboplatin and paclitaxel chemotherapy, is approved for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small cell lung cancer.
Avastin is approved for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
Avastinis approved in combination with paclitaxel and cisplatin or paclitaxel and topotecan for treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
Avastin is approved in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who received no more than two prior chemotherapy regimens.