FDA Approves Bevacizumab With Chemo for Recurrent Ovarian Cancer

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The FDA has approved bevacizumab plus chemotherapy for the treatment of women with platinum-sensitive recurrent ovarian cancer.
The FDA has approved bevacizumab plus chemotherapy for the treatment of women with platinum-sensitive recurrent ovarian cancer.

The U.S. Food and Drug Administration (FDA) has approved bevacizumab (Avastin) in combination with either carboplatin and paclitaxel or carboplatin and gemcitabine for the treatment of women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.1

Approval was granted based on findings from 2 randomized, controlled phase 3 trials, GOG-0213 (ClinicalTrials.gov Identifier: NCT00565851) and OCEANS (ClinicalTrials.gov Identifier: NCT00434642). The GOG-0213 study showed that adding bevacizumab to chemotherapy reduced the risk of death by 18% (hazard ratio [HR], 0.82; 95% CI, 0.68-0.996) when patients were stratified by the duration of platinum-free interval prior to enrolling onto this study as well as secondary surgical debulking status. Median overall survival was 42.6 months with bevacizumab plus chemotherapy vs 37.3 months with chemotherapy alone.

Although the OCEANS study did not show a significantly improved survival rate with the addition of bevacizumab (HR, 0.95; 95% CI, 0.77-1.17), both GOG-0213 and OCEANS demonstrated a significant improvement in progression-free survival.

In GOG-0213 and OCEANS, the addition of bevacizumab reduced the risk of progression or death by 39% (HR, 0.61; 95% CI, 0.51-0.72) and 54% (HR, 0.46; 95% CI, 0.37-0.58; P < .0001), respectively.

RELATED: BI 695502 Demonstrates Bioequivalence to Bevacizumab in Healthy Individuals

The safety profile of bevacizumab in both studies was consistent with previous reports of bevacizumab across tumor types, but also included fatigue, neutropenic fever, hyponatremia, extremity pain, thrombocytopenia, hypertension, headache, and proteinuria.

In addition to being approved for colorectal, non-small cell lung cancer, brain, kidney, and cervical cancers, bevacizumab is approved for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan.

Reference

  1. FDA approves Genentech's Avastin (bevacizumab) plus chemotherapy for a specific type of advanced ovarian cancer. Genentech website. https://www.gene.com/media/press-releases/14647/2016-12-06/fda-approves-genentechs-avastin-bevacizu. Updated December 6, 2016. Accessed December 7, 2016.

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