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FDA approves genetic test for patients with metastatic colorectal cancer
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The FDA recently approved the first genetic test that may help some patients with colorectal cancer and their physicians decide if cetuximab would be an effective treatment based on the lack of a gene mutation.
The therascreen KRAS RGQ PCR Kit (Qiagen Manchester) provides information about the KRAS mutation in patients whose colorectal cancer has metastasized. In those patients, studies have shown that KRAS mutation obstructs the effectiveness of cetuximab (Erbitux; Bristol-Myers Squibb, Eli Lily), which normally targets epidermal growth factor receptor on colorectal cancer cell surfaces and interrupts a signal preventing cell growth.
“This test helps clinicians determine whether this specific treatment is an effective option,” Alberto Gutierrez, PhD, director of the FDA’s office of in vitro diagnostic device evaluation and safety, said in a press release.
The FDA also approved cetuximab to be used in combination with a regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as treatment for patients with metastatic colorectal cancer who have EGFR-expressing and KRAS wild-type tumors.
Study results indicated that patients without KRAS mutations who received cetuximab/FOLFIRI had a median survival of 23.5 months compared with 19.5 months for those who only received FOLFIRI. Among patients with KRAS gene mutation, median survival was similar with or without cetuximab treatment.