US regulators are reviewing a potential new indication for Avastin as a first-line option for advanced ovarian cancer, filed by Roche group Genentech.
The group is seeking approval for Avastin (bevacizumab) in combination with with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.
“About 80 percent of women with ovarian cancer are diagnosed in the advanced stages when the disease is difficult to treat and options are limited,” said Sandra Horning, chief medical officer and head of Global Product Development.
“We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible.”
The application is based on data from the pivotal Phase III GOG-0218 trial, in which women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone.
The FDA is expected to make a decision on approval by June 25, 2018.
Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments.
The drug is also approved for use in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, to treat patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (psOC).