Bevacizumab is now approved by the Food and Drug Administration for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for metastatic colorectal cancer in patients whose disease has progressed on a first-line bevacizumab-containing regimen.
The agency based its approval on results from the 820-patient ML18147 study, funded by Genentech, which markets bevacizumab as Avastin. In that trial, median overall survival for those who received the bevacizumab combination in the first and second line was 11.2 months, compared with 9.8 months for those who had combinations that did not contain bevacizumab. The median progression-free survival was 5.7 months for those receiving the combination with bevacizumab, compared with 4.1 months for the others.
The results of ML18147 were presented at the 2012 American Society of Clinical Oncology annual meeting.
"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," said Dr. Hal Barron, chief medical officer and head of Global Product Development for Genentech, in a statement. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."
The Food and Drug Administration (FDA) said that the safety data from the ML18147 study were similar to bevacizumab’s known safety profile, especially in previous trials of metastatic colorectal cancer.
Genentech noted that this is the third approval for bevacizumab in that disease that is based on improved overall survival. The drug is approved in Europe in combination with fluoropyrimidine-based chemotherapy in metastatic carcinoma of the colon or rectum.
According to the FDA, patients receiving bevacizumab in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy after progression on a first-line bevacizumab-containing regimen should receive 5 mg/kg administered every 2 weeks or 7.5 mg/kg administered every 3 weeks as a 60-minute intravenous infusion.
Full prescribing information is available here.
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