U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens

• Published in: Clinical cancer research Vol. 14; no. 5; pp. 1296 - 1302
• Main Authors: GIUSTI, Ruthann M, SHASTRI, Kaushikkumar, KEEGAN, Patricia, WEISS, Karen D, PAZDUR, Richard, PILARO, Anne M, FUCHS, Chana, CORDOBA-RODRIGUEZ, Ruth, KOTI, Kallappa, ROTHMANN, Mark, MEN, Angela Yuxin, HONG ZHAO, HUGHES, Monica
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA American Association for Cancer Research 01.03.2008
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Chemotherapy, Adjuvant; colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - metabolism; Colorectal Neoplasms - pathology; Disease Progression; Disease-Free Survival; Drug Approval; EGFR; Fluorouracil - administration & dosage; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - metabolism; Liver Neoplasms - secondary; Lung Neoplasms - drug therapy; Lung Neoplasms - metabolism; Lung Neoplasms - secondary; Lymphatic Metastasis; Male; Medical sciences; Middle Aged; monoclonal antibody; Organoplatinum Compounds - administration & dosage; Pharmacology. Drug treatments; Receptor, Epidermal Growth Factor - metabolism; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Survival Rate; targeted therapy; Tumors; United States; United States Food and Drug Administration; Antineoplastic agent; Rectal disease; Colorectal carcinoma; Panitumumab; Colorectal cancer; Monoclonal antibody; Metastasis; Epidermal growth factor receptor; Isomerases; Oxaliplatin; Intestinal disease; Advanced stage; Topoisomerase I inhibitor; Food and Drug Administration; Platinum II Complexes; Camptothecin derivatives; Enzyme; Fluoropyrimidine derivatives; DNA topoisomerase; Enzyme inhibitor; Malignant tumor; Gene expression; Colonic disease; Irinotecan; Alkylating agent; Chemotherapy; Growth factor receptor; Treatment; Digestive diseases; Therapeutic protocol; Cancer
• ISSN: 1078-0432; 1557-3265
• DOI: 10.1158/1078-0432.CCR-07-1354

Purpose: To describe the Food and Drug Administration review and marketing approval considerations for panitumumab (Vectibix) for the third-line treatment of patients with epidermal growth factor receptor–expressing metastatic colorectal carcinoma. Experimental Design: Food and Drug Administration reviewed a single, open-label, multicenter trial in which 463 patients with epidermal growth factor receptor–expressing metastatic colorectal cancer who had progressed on or following treatment with a regimen containing a fluoropyrimidine, oxaliplatin, and irinotecan were randomized (1:1) to receive best supportive care (BSC) with or without panitumumab (6 mg/kg every other week) administered until disease progression or intolerable toxicity. Progression and response were confirmed by an independent review committee masked to treatment assignment. At progression, patients in the BSC-alone arm were eligible to receive panitumumab. Results: Although median progression-free survival (PFS) was similar in both treatment arms (∼8 weeks), the mean PFS was ∼50% longer among patients receiving panitumumab than among those receiving BSC alone (96 versus 60 days, respectively) and the objective response rate in patients receiving panitumumab was 8%. However, no difference in overall survival was shown between the two study arms. Conclusions: Panitumumab received accelerated approval based on improvement in PFS and an independently confirmed response rate of 8%, similar to that observed with other active agents at this advanced stage of disease. Confirmation of clinical benefit will be required for full approval.