Bristol-Myers receives FDA approval for Erbitux use in KRAS wild-type cancer

PBR Staff Writer Published 09 July 2012

Bristol-Myers Squibb (BMY) and Eli Lilly (LLY) have received an approval from US Food and Drug Administration (FDA) to expand the use of Erbitux in combination with the chemotherapy regimen Folfiri as an initial treatment of patients with KRAS mutation-negative colorectal cancer.

KRAS mutation-negative colorectal cancer is also commonly known as KRAS wild-type.

Concurrently, the FDA has also approved the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit developed by Netherlands-based Qiagen.

Bristol-Myers Squibb senior vice president of Global Development and Medical Affairs, Brian Daniels said, "Today's approval demonstrates our ability to bring diverse cancer therapies to market that address the needs of patients with KRAS mutation-negative (wild-type) mCRC."

Following the approval, Erbitux has now become the first and only FDA-approved therapy for a specific subset of mCRC patients, targeting those with KRAS wild-type tumors.

Erbitux is, however, not indicated for the treatment of KRAS mutation-positive colorectal cancer.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/bristol-myers-receives-fda-approval-for-erbitux-use-in-kras-wild-type-cancer-090712

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