Roche has announced that the US Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection.

“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” said Sandra Horning, MD, Roche’s chief medical officer and head of global product development. “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.”

The approval for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the treatment of women with stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, is based on data from the pivotal phase III GOG-0218 trial. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.62; 95% CI 0.52 - 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total).1

Avastin is now approved for ten distinct uses across six different types of cancer in the United States. This indication represents Avastin’s fourth gynaecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.

GOG-0218 (NCT00262847) is a multi-centre, randomised, double-blind, placebo-controlled, phase III study in 1,873 women with previously untreated stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumour as possible. Participants were randomied into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone for a total of up to 22 cycles. The primary endpoint of the study was investigator-assessed PFS and secondary endpoints included overall survival (OS). The study was conducted by the Gynecologic Oncology Group (GOG) and initial results were previously published in the New England Journal of Medicine.

Ovarian cancer causes more deaths among women than any other gynaecologic cancer in the United States. In 2018, more than 22,000 women will be diagnosed with ovarian cancer in the US and about 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly and/or frequent urination, are present, they can be associated by other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

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