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FDA approves Avastin plus chemotherapy regimen for mCRC
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The FDA has approved the use of bevacizumab combined with chemotherapy for patients with metastatic colorectal cancer whose disease progressed after first-line treatment with a bevacizumab-containing regimen.
The approval allows treatment with bevacizumab (Avastin, Genentech) plus fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin chemotherapy.
The recommended dose and schedule in the targeted patient population is 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks as a 60-minute IV infusion.
The FDA based its approval on results of a randomized, open-label, multinational trial that evaluated patients with metastatic colorectal cancer (mCRC) that progressed during or within 3 months of discontinuation of first-line, bevacizumab-based combination chemotherapy with fluoropyrimidine/oxaliplatin or fluoropyrimidine/irinotecan.
Researchers randomly assigned 820 patients to receive crossover chemotherapy alone (n=411) or combined with bevacizumab (n=409).
OS served as the primary endpoint.
Researchers observed a significant improvement in OS among patients who received the combination therapy compared with chemotherapy alone (11.2 months vs. 9.8 months; HR=0.81; 95% CI, 0.69-0.94).
The combination therapy also conferred a significant improvement in median PFS (5.7 months vs. 4 months; HR=0.68; 95% CI, 0.59-0.78), study results showed.
Researchers did not observe new safety signals in the trial, and safety data were consistent with bevacizumab’s known safety profile, according to the FDA.