FDA Approves ERBITUX(R) (cetuximab) As First-Line Treatment In KRAS Mutation-Negative (Wild-Type) Epidermal Growth Factor Receptor (EGFR)-Expressing Metastatic Colorectal Cancer In Combination With FOLFIRI (Irinotecan, 5-Fluorouracil, Leucovorin)

Eli Lilly and Company (NYSE: LLY) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that ERBITUX ^® (cetuximab) in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX is not indicated for the treatment of KRAS mutation-positive colorectal cancer. Concurrently, the FDA also approved the first KRAS companion diagnostic test, the therascreen ^® KRAS diagnostic kit developed by QIAGEN.

“Cancer is a heterogeneous disease and we have learned that not all patients with mCRC should be viewed as the same,” said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “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.”

The new indication is based on data from the CRYSTAL ( Cetuximab combined with i Rinotecan in first-line therap Y for meta STatic colorect AL cancer) trial, a Phase 3 open-label, randomized, multicenter study conducted outside the U.S. that used European Union (EU)-approved cetuximab as the clinical trial material. ERBITUX provides approximately 22 percent higher exposure relative to the EU-approved cetuximab; these pharmacokinetic data, together with the results of this trial and other clinical trial data, establish the efficacy of ERBITUX at the recommended dose in combination with FOLFIRI for first-line KRAS mutation-negative (wild-type) EGFR-expressing mCRC.

With today’s approval, ERBITUX is now the first and only FDA-approved therapy for a specific subset of mCRC patients, targeting those with KRAS mutation-negative (wild-type) tumors. This is based on the positive CRYSTAL study with progression-free survival (PFS) as the primary endpoint in the all randomized patient population treated with EU-approved cetuximab plus FOLFIRI (the CRYSTAL regimen) versus FOLFIRI alone.

The Full Prescribing Information for ERBITUX includes a Boxed WARNING regarding infusion reactions. Serious infusion reactions occurred with the administration of ERBITUX in approximately 3 percent of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. Healthcare providers should immediately interrupt and permanently discontinue ERBITUX infusion for serious infusion reactions.

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