Bevacizumab Plus Chemotherapy Receives FDA Approval for Ovarian Cancer

December 14, 2016

Bevacizumab (Avastin), an intravenous drug manufactured by Genentech, has received US Food and Drug Administration (FDA) approval for the treatment of platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer based on two phase III clinical trial results.

Bevacizumab (Avastin), an intravenous drug manufactured by Genentech, has received US Food and Drug Administration (FDA) approval for the treatment of platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer based on two phase III clinical trial results.1

The clinical trials, GOG-0213 and OCEANS, both reveled positive outcomes for women with these cancers. Specifically, GOG-0213’s study results, which demonstrated that women experienced a 5-month increase in overall survival with the addition of bevacizumab to chemotherapy, and both GOG-0213 and OCEANS revealed improved progression-free survival times.

Bevacizumab), a biologic antibody, is intended to interrupt tumor angiogenesis (blood vessel formation). This is accomplished by binding to the protein VEGF (vascular endothelial growth factor) in an attempt to stop the tumor’s blood supply and decrease metastasis.

The angiogenesis inhibitor will now be available to women in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab only after completion of treatment with the other combination of drugs. It is already available to treat other gynecologic malignancies, including certain cervical cancers and platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers.1

In addition to the side effects of bevacizumab) in other trials such as epistaxis, headache, hypertension, nasal inflammation, proteinuria, taste changes, dry skin, rectal bleeding, tear production disorder, back pain, and exfoliative dermatitis, the GOG-0213 and OCEANS study participants also experienced fatigue, febrile neutropenia, hyponatremia, extremity pain, thrombocytopenia, proteinuria, hypertension, and headache.

Along with the aforementioned side effects, bevacizumab is also associated with serious and potentially fatal gastrointestinal perforation, delayed or complicated wound healing, severe bleeding, fistula formation, stroke, heart problems, proteinuria, renal dysfunction, blood clots, severe hypertension, posterior reversible encephalopathy syndrome, infusion reactions, ovarian failure with impaired fertility, and fetal risks.

References:

1. Genentech, Inc. FDA Approves Genentech’s Avastin® (Bevacizumab) Plus Chemotherapy for a Specific Type of Advanced Ovarian Cancer. Press release. 2016 Dec 6.