FDA Approves Avastin in Combination with Chemotherapy as Treatment for Advanced Ovarian Cancers

FDA Approves Avastin in Combination with Chemotherapy as Treatment for Advanced Ovarian Cancers

The U.S. Food and Drug Administration (FDA) has approved the use of Avastin (bevacizumab) in combination with standard chemotherapy, followed by Avastin alone, as a front-line treatment for advanced ovarian cancers.

This label extension is for women who have already undergone surgery and represents Avastin’s fourth indication as a treatment for gynecologic cancers. These include the treatment of advanced cervical cancer and two different forms of recurrent, platinum-resistant ovarian cancer.

“This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery,” Melissa Aucoin, interim CEO of the National Ovarian Cancer Coalition, said in a press release. “Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers.”

The decision was supported by clinical data from the GOG-0218 Phase 3 trial (NCT00262847).

The study assessed the safety and efficacy of Avastin in 1,873 women with epithelial ovarian carcinoma, primary peritoneal, or fallopian tube carcinoma whose only treatment had been surgery to remove a tumor.

Participants were randomized into three groups: one that received a chemotherapy regimen of Paraplatin (carboplatin) plus Taxol (paclitaxel); one that received chemotherapy plus Avastin; and a third that received a combination of chemotherapy plus Avastin followed by Avastin alone.

Women who received Avastin with chemotherapy followed by Avastin alone lived the longest without signs of disease progression, at 18.2 months. This was 5.4 months longer than those who received the combination only, and 6.2 months longer compared to chemotherapy alone.

Collectively, treatment with Avastin plus chemotherapy followed by Avastin alone represented a reduction of 38 percent in the risk of disease progression or death compared to chemotherapy alone.

“We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death,” said Sandra Horning, chief medical officer and head of global product development at Genentech.

The company has created an Access Solutions program to help patients access Genentech’s therapies regardless of their ability to pay. The program can help patients in the United States navigate the access and reimbursement process by providing assistance to eligible patients who do not have health insurance or cannot afford the treatment.

For further information about the program, contact Access Solutions in the U.S. at 1 (866) 422-2377 or visit www.Genentech-Access.com.