The latest approval from the US Food and Drug Administration (FDA) is for use of bevacizumab, together with chemotherapy, in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The drug is already approved for use in patients with platinum-resistant ovarian cancer, as well as in several other cancer types.
Women are said to have a “platinum-sensitive” form of the disease if a relapse occurs after 6 months or longer following the last treatment with a platinum-based chemotherapy. They are considered to have a “platinum-resistant” form of the disease if a relapse occurs less than 6 months after the last treatment with a platinum-based chemotherapy. About half of patients fall into each category.
The new approval in platinum-sensitive patients covers use of bevacizumab in combination with either carboplatin and paclitaxel or carboplatin and gemcitabine chemotherapy, followed by bevacizumab use alone.
It is based on two phase 3 trials, the GOG-0213 and the OCEANS studies.
Results from the GOG-0213 study showed that patients treated with bevacizumab added onto chemotherapy lived for about 5 months longer than those treated with chemotherapy alone (median overall survival [OS], 42.6 months vs 37.3 months; hazard ratio, 0.84 or 0.82, depending on stratification factor). Although it just missed achieving statistical significance, this was considered by investigators to be a “clinically meaningful” improvement in OS.
The other trial, known as OCEANS, did not show a survival benefit, but both trials showed a significant improvement in progression-free survival when bevacizumab was added onto chemotherapy.
Bevacizumab was approved for use in patients with platinum-resistant ovarian cancer in November 2014, on the basis of the phase 3 AURELIA study. Results from this study showed that adding bevacizumab to chemotherapy led to a statistically significant improvement in progression-free survival and objective response rate over standard chemotherapy alone, although there was no OS benefit.
The latest approval “demonstrates Genentech’s commitment to women with ovarian cancer, a disease with signs and symptoms that too often go unrecognized,” David Barley, chief executive officer, National Ovarian Cancer Coalition (NOCC), commented in a company press release.
Ovarian cancer causes more deaths than any other gynecologic cancer in the United States, the company notes. In 2016, about 22,200 women will be diagnosed with ovarian cancer in the United States and about 14,200 will die of the disease.
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