FDA Approves Bevacizumab in Combination with Chemotherapy for Patients with PPC & Fallopian Tube Can

The US Food and Drug Administration (FDA) has approved bevacizumab for patients with ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for either stage 3 or 4 disease post-initial surgical resection.

The FDA based their decision on data yielded from a multicenter, randomized, double-blind study, referred to as GOG-0218, that assessed the addition of bevacizumab to carboplatin and paclitaxel in patients with stage 3 or 4 epithelial ovarian, fallopian tube, or primary peritoneal cancer post-initial surgical resection.

A total of 1,873 patients were enrolled in the study, and investigators randomized them into 3 treatment arms: those who would receive carboplatin plus paclitaxel without bevacizumab, those administered carboplatin plus paclitaxel with bevacizumab for up to 6 cycles, or those who would receive carboplatin plus paclitaxel with bevacizumab for 6 cycles followed by single-agent bevacizumab for up to 16 additional doses. The investigators administered 15 mg/kg of bevacizumab every 3 weeks. In total, 1,215 patients received at least 1 dose of the newly approved drug.

They defined the primary efficacy outcome as investigator-assessed progression-free survival (PFS); a secondary outcome was overall survival (OS). They found that patients who were receiving bevacizumab with chemotherapy followed by single-agent bevacizumab had an estimated median PFS as 18.2 months. Those who received bevacizumab with chemotherapy but without single-agent bevacizumab had an estimated median PFS as 12.8 months. The last arm, those who received chemotherapy without bevacizumab had an estimated median PFS of 12.0 months.

Furthermore, investigators reported that those who received bevacizumab with chemotherapy followed by single-agent bevacizumab had a higher median OS (43.8 months) than those who just received chemotherapy by itself (40.6 months).

The most common adverse events reported in the GOG-0218 study for those receiving bevacizumab consisted of the following: diarrhea, nausea, stomatitis, fatigue, arthralgia, muscular weakness, pain in extremity, dysarthria, headache, dyspnea, epistaxis, nasal mucosal disorder, and hypertension, according to the announcement. Furthermore, grade 3-4 adverse events that occurred in either of the treatment arms receiving bevacizumab compared with the control included fatigue, hypertension, a decrease in platelet count as well as white blood cell count.

The recommended dose is 15 mg/kg every 3 weeks along with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg of single-agent bevacizumab every 3 weeks for up to 22 cycles.

The FDA has granted orphan product designation for this indication as well.