The U.S. Food and Drug Administration (FDA) approved Genentech’s Avastin in combination with chemotherapy for the treatment of platinum-sensitive recurrent ovarian cancer (psOC). This marks the first new psOC treatment option approved by the FDA in more than a decade.
The FDA approval was based on results from two large Phase 3 studies evaluating Avastin (GOG-0213) in women with ovarian cancer. The results provided evidence there was a significant overall survival rate for women with psOC who were treated with Avastin and chemotherapy, versus chemotherapy alone.
“With today’s approval of Avastin plus chemotherapy, women in the U.S. with recurrent, platinum-sensitive ovarian cancer now have a treatment option that showed a survival difference of more than five months compared to chemotherapy alone in a clinical trial,” Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech, said in a press release.
“This approval was based in part on a Gynecologic Oncology Group cooperative clinical trial and reinforces the importance of partnerships with study groups to identify new treatment options for people in need,” she said.
Horning’s colleague at the National Ovarian Cancer Coalition (NOCC), David Barley, shared her enthusiasm.
“In the United States, ovarian cancer causes more deaths annually than any other gynecologic cancer. This approval demonstrates Genentech’s commitment to women with ovarian cancer, a disease with signs and symptoms that too often go unrecognized,” he said.
According to Genetech, by the end of 2016 approximately 22,200 women will be diagnosed and 14,200 will die from ovarian cancer.
Both the GOG-0213 and OCEANS Phase 3 studies demonstrated significant improvements in the time women lived without their disease getting worse, called progression-free survival, or PFS. The GOG-0213 study showed that Avastin combined with chemotherapy showed that women lived a median of 3.4 months longer without disease progression and an overall survival difference of five months compared to chemotherapy alone.
The OCEANS study demonstrated that Avastin added to chemotherapy significantly improved PFS by four months compared to a placebo plus chemotherapy, but overall survival was not significantly improved in the OCEANS study.