FDA News

FDA approves Avastin plus chemotherapy for ovarian cancer after surgery

The FDA approved bevacizumab for use with chemotherapy, followed by bevacizumab as a single agent, for the treatment of women with advanced ovarian cancer who underwent initial surgical resection.

Bevacizumab (Avastin, Genentech) is now approved for 10 indications in the United States. These include advanced cervical cancer and two forms of ovarian cancer that recurred after platinum-based chemotherapy.

The FDA based the newest approval on results from the phase 3 GOG-0218 trial, which assessed 1,873 women with previously untreated stage III or stage IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma.

All women underwent surgical resection.

Researchers then randomly assigned women to one of three regimens: chemotherapy alone with carboplatin and paclitaxel; bevacizumab 15 mg/kg plus chemotherapy followed by placebo; or bevacizumab plus chemotherapy followed by bevacizumab alone. Treatment continued for up to 22 cycles.

Results showed women assigned bevacizumab plus chemotherapy followed by bevacizumab alone achieved longer median PFS (18.2 months) than those assigned bevacizumab plus chemotherapy followed by placebo (12.8 months) and those who received chemotherapy alone (12 months). Researchers calculated an HR of 0.62 (95% CI, 0.52-0.75) for bevacizumab-chemotherapy followed by chemotherapy compared with chemotherapy alone.

Women assigned bevacizumab plus chemotherapy followed by bevacizumab also achieved longer median OS than those who received chemotherapy alone, although the improvement did not reach statistical significance (43.8 months vs. 40.6 months; HR = 0.89; 95% CI, 0.76-1.05).

“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We’re committed to advancing medicines in areas of unmet need, and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death.”

The most common grade 3 or grade 4 adverse events associated with bevacizumab plus chemotherapy followed by bevacizumab alone included decreased white blood cell count (51%), decreased platelet count (21%), high blood pressure (10%) and fatigue (9%).

The FDA approved bevacizumab for use with chemotherapy, followed by bevacizumab as a single agent, for the treatment of women with advanced ovarian cancer who underwent initial surgical resection.

Bevacizumab (Avastin, Genentech) is now approved for 10 indications in the United States. These include advanced cervical cancer and two forms of ovarian cancer that recurred after platinum-based chemotherapy.

The FDA based the newest approval on results from the phase 3 GOG-0218 trial, which assessed 1,873 women with previously untreated stage III or stage IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma.

All women underwent surgical resection.

Researchers then randomly assigned women to one of three regimens: chemotherapy alone with carboplatin and paclitaxel; bevacizumab 15 mg/kg plus chemotherapy followed by placebo; or bevacizumab plus chemotherapy followed by bevacizumab alone. Treatment continued for up to 22 cycles.

Results showed women assigned bevacizumab plus chemotherapy followed by bevacizumab alone achieved longer median PFS (18.2 months) than those assigned bevacizumab plus chemotherapy followed by placebo (12.8 months) and those who received chemotherapy alone (12 months). Researchers calculated an HR of 0.62 (95% CI, 0.52-0.75) for bevacizumab-chemotherapy followed by chemotherapy compared with chemotherapy alone.

Women assigned bevacizumab plus chemotherapy followed by bevacizumab also achieved longer median OS than those who received chemotherapy alone, although the improvement did not reach statistical significance (43.8 months vs. 40.6 months; HR = 0.89; 95% CI, 0.76-1.05).

“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We’re committed to advancing medicines in areas of unmet need, and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death.”

The most common grade 3 or grade 4 adverse events associated with bevacizumab plus chemotherapy followed by bevacizumab alone included decreased white blood cell count (51%), decreased platelet count (21%), high blood pressure (10%) and fatigue (9%).