FDA Approves Avastin® Plus Chemotherapy for Treatment of Advanced Ovarian Cancer
Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy.
Approval was based on two large comparative clinical studies including GOG-0213 that showed a five month improvement in overall survival for women with platinum-sensitive recurrent ovarian cancer who were treated with Avastin plus chemotherapy compared to chemotherapy alone.
About Ovarian Cancer
Each year in the United States, roughly 22,000 women are diagnosed with ovarian cancer and more than 15,000 die of the disease. Treatment for ovarian cancer commonly involves surgery and/or chemotherapy, but outcomes for women diagnosed with advanced disease remain poor, and researchers continue to evaluate new approaches to treatment. About half of those who relapse after initial treatment – over 8,000 women – will have platinum-sensitive ovarian cancer.
Avastin is a targeted therapy that blocks a protein known as VEGF. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth. Currently, Avastin is used for the treatment of selected patients with lung cancer, colorectal cancer, kidney cancer, or glioblastoma.
In November 2014, Avastin was approved in the United States for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy. Women are considered to have a ‘platinum-resistant’ form of the disease if a relapse occurs less than six months after the last treatment with a platinum-based chemotherapy.
About the Clinical Study
GOG-0213 is an independent comparative clinical trial sponsored by the National Cancer Institute (NCI) and conducted by the Gynecologic Oncology Group (GOG) that enrolled 673 women with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. The primary endpoint of the study was to assess whether the addition of Avastin to chemotherapy (carboplatin and paclitaxel) followed by continued use of Avastin alone increased overall survival (OS) compared to chemotherapy alone. Progression-free survival (PFS) and objective response rate (ORR) were secondary endpoints in the GOG-0213 study.
- Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy.
- Across cancer types, 0.4% to 6.9% of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.
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