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FDA approves genetic test, cetuximab/FOLFIRI for 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, according to a press release.
The therascreen KRAS RGQ Polymerase Chain Reaction Kit (Quiagen Manchester) provides information about KRAS gene mutation in patients whose colorectal cancer (CRC) has metastasized. In those patients, studies have shown that KRAS gene mutation obstructs the effectiveness of cetuximab (Erbitux; Bristol-Myers Squibb, Eli Lilly), which normally targets epidermal growth factor receptor (EGFR) on CRC 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 the release.
The FDA also approved Erbitux to be used in combination with a regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as treatment for patients with metastatic CRC who have EGFR-expressing and KRAS wild-type tumors.
Study results indicated that patients without KRAS mutations who received Erbitux/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 Erbitux treatment.