publication date: Jun. 15, 2018
Drugs and Targets
FDA approves Avastin in combination with chemotherapy for ovarian cancer
FDA has approved bevacizumab (Avastin) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.
The drug is sponsored by Genentech, a unit of Roche.
Approval was based on GOG-0218 (NCT00262847), a multicenter, randomized, double-blind, placebo-controlled, three-arm study evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
Patients (n=1,873) were randomized (1:1:1) to carboplatin plus paclitaxel without bevacizumab, carboplatin plus paclitaxel with bevacizumab for up to six cycles, or carboplatin plus paclitaxel with bevacizumab for six cycles followed by single-agent bevacizumab for up to 16 additional doses. Bevacizumab was administered at 15 mg/kg intravenously every three weeks. On this trial, 1,215 patients received at least one bevacizumab dose.
The primary efficacy outcome was investigator-assessed progression-free survival; overall survival was a secondary outcome. The estimated median PFS was 18.2 months for patients receiving bevacizumab with chemotherapy followed by single-agent bevacizumab (HR 0.62; 95% CI: 0.52, 0.75; p<0.0001). For those receiving bevacizumab with chemotherapy without single-agent bevacizumab, the estimated median PFS was 12.8 months (HR 0.83; 95% CI: 0.70, 0.98; not significant).
For patients receiving chemotherapy without bevacizumab, the estimated median PFS was 12.0 months. Estimated median OS was 43.8 months in the bevacizumab with chemotherapy followed by bevacizumab compared to 40.6 months in the chemotherapy alone arm (HR 0.89; 95% CI: 0.76, 1.05).
Adverse reactions occurring at higher incidence (at least … Continue reading FDA approves Avastin in combination with chemotherapy for ovarian cancer
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