U.S. Food and Drug Administration (FDA) has approved Roche’s 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.
“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,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “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.”
Avastin in combination with chemotherapy for platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer was granted priority review, and today’s approval is based on results from two randomised, controlled Phase III studies, GOG-0213 and OCEANS.
Read furteher on Roche website