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news.The FDA has expanded the approved indication for Genentech's anticancer drug Avastin by giving the go-ahead for the compound to be used, in combination with 5-FU-based chemotherapy, for the treatment of second-line metastatic colorectal cancer.
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This expands the indication for the drug, which is marketed by Roche in Europe, making it available for use in the treatment of second-line as well as the previously approved first-line treatment of the disease.
“Avastin is the only biologic therapy with a demonstrated survival benefit in colorectal cancer, and this new indication offers CRC patients who have received a previous treatment regimen a new option to help fight their disease,” said Dr Hal Barron, chief medical officer at Genentech.
The new approval is based on results of a randomized, controlled, multicenter phase III trial of 829 patients with advanced or metastatic CRC who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvent therapy.
The approval is based on a 829 patient study in which patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 had a 25% reduction in the risk of death, the primary endpoint, which is equivalent to a 33% improvement in overall survival, compared to patients who received FOLFOX4 alone.
Median survival for patients receiving Avastin plus FOLFOX4 was 13 months, compared to 10.8 months for those receiving FOLFOX4 alone.
The drug is also in development for kidney, breast, pancreatic, non-small cell lung, prostate and ovarian cancers.