What is the generic name?

PANITUMUMAB

What is the Trade Name for PANITUMUMAB?

Vectibix

What are the Indications for PANITUMUMAB?

• 1 INDICATIONS AND USAGE Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use ) metastatic colorectal cancer (mCRC): In combination with FOLFOX for first-line treatment. ( 1.1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1.1 , 14.1 ) Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC or for whom RAS mutation status is unknown. ( 1.1 , 2.1 , 5.2 , 12.1 ) 1.1 Metastatic Colorectal Cancer Vectibix is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) [see Dos age and Administration ( 2.1 )] : ‚Ä¢ As first-line therapy in combination with FOLFOX [ see Clinical Studies ( 14.2 )] . ‚Ä¢ As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see Clinical Studies ( 14.1 )] . Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC or for whom RAS mutation status is unknown [see Dosage and Administration ( 2.1 ) , Warnings and Precautions ( 5.2 ) , and Clinical Pharmacology ( 12.1 ) ].

References: https://open.fda.gov/