The Food and Drug Administration approved bevacizumab (Avastin), used in combination with certain types of chemotherapy, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary perioneal cancer.
The FDA approved its use in combination with either carboplatin and paclitaxel or carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone. In November 2014, the FDA approved bevacizumab for use in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy for women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The Dec. 6 approval is based on results from two randomized controlled phase III studies that showed a significant improvement in progression-free survival.
The GOG-0213 study showed an overall survival improvement of 5 months with bevacizumab plus chemotherapy, compared with chemotherapy alone (hazard ratio, 0.84). The study also showed improved progression-free survival of 3.4 months (HR, 0.61). In the OCEANS study, progression-free survival was 12.4 months for bevacizumab plus chemotherapy, compared with 8.4 months for placebo plus chemotherapy (HR, 0.46). Overall survival was not significantly improved by the addition of bevacizumab in the OCEANS study.
Some adverse events observed in the trials included fatigue, hypertension, febrile neutropenia, proteinuria, abdominal pain, hyponatremia, headache, nausea, and pain in the extremity.
Bevacizumab is manufactured by Genentech, and full prescribing information and a boxed warning are available on the drug’s website, www.avastin.com.
mschneider@frontlinemedcom.com
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