FDA has announced it has approved the first genetic test that can help some colorectal cancer patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation, according to a news release.
The therascreen KRAS RGQ PCR Kit, developed by England-based QIAGEN Manchester, is designed to provide information about the KRAS gene mutation in patients whose colorectal cancer has spread to other parts of their body. Studies have found that Eribitux is not effective in those who have the mutation.
FDA also approved a new indication for Erbitux for use in combination with FOLFIRI, chemotherapy drugs consisting of irinotecan, 5-fluorouracil, and leucovorin, as a first-line treatment in patients with metastatic colorectal cancer who have epidermal growth factor receptor-expressing, and KRAS wild-type (no mutations) tumors.
Erbitux is co-marketed by Bristol-Myers Squibb and Eli Lilly and Co.
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