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1 Indications And Usage Erbitux ® Is An Epidermal Growth Factor Receptor (Egfr) Antagonist Indicated For Treatment Of: Head And Neck Cancer Locally Or Regionally Advanced Squamous Cell Carcinoma Of The Head And Neck In Combination With Radiation Therapy. ( 1.1 , 14.1 ) Recurrent Locoregional Disease Or Metastatic Squamous Cell Carcinoma Of The Head And Neck In Combination With Platinum-Based Therapy With Fluorouracil. ( 1.1 , 14.1 ) Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck Progressing After Platinum-Based Therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras Wild-Type, Egfr-Expressing, Metastatic Colorectal Cancer As Determined By An Fda-Approved Test In Combination With Folfiri For First-Line Treatment, In Combination With Irinotecan In Patients Who Are Refractory To Irinotecan-Based Chemotherapy, As A Single Agent In Patients Who Have Failed Oxaliplatin- And Irinotecan-Based Chemotherapy Or Who Are Intolerant To Irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations Of Use: Erbitux Is Not Indicated For Treatment Of Ras-Mutant Colorectal Cancer Or When The Results Of The Ras Mutation Tests Are Unknown. ( 5.7 ) 1.1 Squamous Cell Carcinoma Of The Head And Neck (Scchn) Erbitux ® Is Indicated: In Combination With Radiation Therapy For The Initial Treatment Of Locally Or Regionally Advanced Squamous Cell Carcinoma Of The Head And Neck (Scchn). In Combination With Platinum-Based Therapy With Fluorouracil For The First-Line Treatment Of Patients With Recurrent Locoregional Disease Or Metastatic Scchn. As A Single Agent For The Treatment Of Patients With Recurrent Or Metastatic Scchn For Whom Prior Platinum-Based Therapy Has Failed. 1.2 K-Ras Wild-Type, Egfr-Expressing Colorectal Cancer (Crc) Erbitux Is Indicated For The Treatment Of K-Ras Wild-Type, Epidermal Growth Factor Receptor (Egfr)-Expressing, Metastatic Colorectal Cancer (Mcrc) As Determined By An Fda-Approved Test [See Dosage And Administration ( 2.2 )] : In Combination With Folfiri (Irinotecan, Fluorouracil, Leucovorin) For First-Line Treatment, In Combination With Irinotecan In Patients Who Are Refractory To Irinotecan-Based Chemotherapy, As A Single Agent In Patients Who Have Failed Oxaliplatin- And Irinotecan-Based Chemotherapy Or Who Are Intolerant To Irinotecan. Limitations Of Use: Erbitux Is Not Indicated For Treatment Of Ras-Mutant Colorectal Cancer Or When The Results Of The Ras Mutation Tests Are Unknown [See Warnings And Precautions ( 5.7 )] .
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