On June 13, 2018, the FDA approved bevacizumab (Avastin; Genentech), in combination with carboplatin and paclitaxel, for the treatment of patients with resected, stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, to be followed with bevacizumab monotherapy. Bevacizumab received orphan drug designation for this indication.
This approval was based on a multicenter, double-blind, placebo-controlled clinical trial of 1873 patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who had initial surgical resection. Patients were randomized to carboplatin plus paclitaxel; carboplatin plus paclitaxel with bevacizumab (for up to 6 cycles); or carboplatin plus paclitaxel with bevacizumab for 6 cycles, followed by bevacizumab monotherapy for up to 16 additional doses. Bevacizumab was administered intravenously every 3 weeks. A total of 1215 patients received ≥1 bevacizumab doses.
In patients receiving bevacizumab plus chemotherapy followed by bevacizumab, the median progression-free survival (PFS) was 18.2 months compared with 12.8 months for those receiving bevacizumab plus chemotherapy but no follow-up with bevacizumab monotherapy. The median PFS was 12 months with chemotherapy alone. The estimated median overall survival for the bevacizumab plus chemotherapy followed by bevacizumab arm was 43.8 months versus 40.6 months in the chemotherapy alone arm.
The most common (≥2%) grade 3 or 4 adverse events with bevacizumab were fatigue, hypertension, thrombocytopenia, and leukopenia.