FDA approves Erbitux(Eli Lilly/BMS)for first line combination treatment of Kras wild type EGFR expressing metastatic Colorectal Cancer - 08-Jul-2012

Erbitux (cetuximab), marketed by BMS/Eli Lilly in the U.S.,in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the 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.The new indication is based on data from the CRYSTAL trial, a Phase III 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 this 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.Erbitux is marketed outside the U.S. by Merck Serono.