Regulatory Affairs

FDA approves Roche's Avastin plus chemotherapy for ovarian cancer after surgery

Published 14 June 2018

The US Food and Drug Administration (FDA) has approved Roche’s Avastin (bevacizumab) plus chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with stage III or IV ovarian cancer following initial surgical resection.

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

“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).

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.

Source: Company Press Release.