The U.S. Food and Drug Administration has accepted for review Genentech‘s supplemental Biologics License Application (sBLA) seeking the approval of Avastin (bevacizumab) in combination with chemotherapy, as a front-line treatment for women with advanced ovarian cancer. The FDA’s decision is expected by June 25, 2018.
Front-line treatment in ovarian cancer is the first treatment a woman receives after surgery.
“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,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release. “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 sBLA is based on data from the GOG-0218 Phase 3 clinical trial (NCT00262847), reported in 2011. The study included 1,873 women with previously untreated epithelial ovarian carcinoma, primary peritoneal, or fallopian tube carcinoma, whose tumors already had been surgically removed.
Participants were randomly assigned chemotherapy alone (Paraplatin (carboplatin) plus Taxol (paclitaxel)), chemotherapy plus Avastin followed by placebo, or chemotherapy plus Avastin, followed by Avastin alone.
Those in the last treatment group (Avastin alone) lived the longest without disease progression, the study found. Compared to participants receiving Avastin plus chemotherapy, those who continued using Avastin took six more months before seeing their disease progress (18.2 months vs. 12 months), representing a 36 percent reduction in the risk of progression.
Adverse events were similar to those seen in trials of Avastin across other tumor types. The trial was funded by the National Cancer Institute and Genentech.
The results of the trial were reported in a 2011 article “Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer,” published in the New England Journal of Medicine.
Genentech is now evaluating Avastin in combination with Tecentriq (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer in the Phase 3 IMagyn050 trial (NCT03038100).
Avastin has been approved, in combination with Taxol, pegylated liposomal Adriamycin (doxorubicin), or Hycamtin (topotecan), for treating recurrent ovarian cancer patients who received two or fewer chemotherapy regimens and do not respond to platinum treatment (platinum-resistant).
Avastin, in combination with either Paraplatin and Taxol, or Paraplatin and Gemzar (gemcitabine), followed by Avastin alone, also is approved for the treatment of patients with recurrent ovarian cancer that responds to platinum treatment (platinum-sensitive).
Avastin is available as a solution for intravenous infusion. It is an antibody that targets the vascular endothelial growth factor (VEGF) protein. VEGF promotes a process called angiogenesis, helping the tumor to develop and maintain blood vessels. Avastin is designed to interfere with the tumor blood supply, which is thought to be crucial to a tumor’s ability to grow and spread to other parts of the body (metastasize).