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Bevacizumab (Avastin) may improve progression-free survival among treatment-naïve patients with ovarian cancer.
Genentech recently announced that the FDA has accepted the supplemental biologics application (sBLA) for bevacizumab (Avastin) plus carboplatin and paclitaxel chemotherapy followed by bevacizumab as a first-line therapy for patients with advanced ovarian cancer.
Clinical trials showed that this combination therapy offered benefits to patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, according to a press release.
Currently, the first treatment patients with advanced ovarian cancer receive is surgery, which may significantly impact quality of life.
The sBLA was based on positive results from the phase 3 GOG-0218 clinical trial. Included in the study were 1873 treatment-naïve patients with advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who had received surgical intervention.
Patients were randomized to either receive chemotherapy (carboplatin and paclitaxel), bevacizumab plus chemotherapy followed by placebo, or bevacizumab plus chemotherapy followed by bevacizumab monotherapy.
Genentech found that patients administered bevacizumab plus chemotherapy followed by bevacizumab had progression free survival of 18.2 months compared with 12 months in patients administered chemotherapy alone, according to the release. Secondary endpoints of the trial included overall survival and overall response rate.
Common adverse events in the trial were consistent with its known safety profile. Genentech reported that common side effects of the therapy include nosebleeds, headache, high blood pressure, inflammation of the nose, high levels of protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and skin inflammation, according to the release.
Bevacizumab has previously been approved to treat colorectal cancer, non-small cell lung cancer, renal cell carcinoma, carcinoma of the cervix, and ovarian cancer.
Genentech is also exploring a combination of bevacizumab plus atezolizumab (Tecentriq) plus chemotherapy in patients with advanced ovarian cancer in an effort to present patients with more treatment options, according to the release.
“About 80% 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, MD, chief medical officer and head of Global Product Development, Genentech. “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.”
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