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  • 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
  • Giusti RM; Shastri K; Pilaro AM; Fuchs C; Cordoba-Rodriguez R; Koti K; Rothmann M; Men AY; Zhao H; Hughes M; Keegan P; Weiss KD; Pazdur R
  • Clin Cancer Res 2008[Mar]; 14 (5): 1296-302
  • 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 ( approximately 8 weeks), the mean PFS was approximately 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.
  • |*Drug Approval[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Antibodies, Monoclonal/administration & dosage[MESH]
  • |Antineoplastic Combined Chemotherapy Protocols/*therapeutic use[MESH]
  • |Camptothecin/administration & dosage/analogs & derivatives[MESH]
  • |Chemotherapy, Adjuvant[MESH]
  • |Colorectal Neoplasms/*drug therapy/metabolism/pathology[MESH]
  • |Disease Progression[MESH]
  • |Disease-Free Survival[MESH]
  • |ErbB Receptors/*metabolism[MESH]
  • |Fluorouracil/administration & dosage[MESH]
  • |Humans[MESH]
  • |Irinotecan[MESH]
  • |Liver Neoplasms/*drug therapy/metabolism/secondary[MESH]
  • |Lung Neoplasms/*drug therapy/metabolism/secondary[MESH]
  • |Lymphatic Metastasis[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Organoplatinum Compounds/administration & dosage[MESH]
  • |Oxaliplatin[MESH]
  • |Panitumumab[MESH]
  • |Survival Rate[MESH]
  • |United States[MESH]
  • |United States Food and Drug Administration[MESH]





  • *{{pmid18316547}}
    *<b>[http://www.kidney.de/mlpefetch.php?search=18316547 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 ]</b> Clin Cancer Res 2008; 14(5) ; 1296-302 Giusti RM; Shastri K; Pilaro AM; Fuchs C; Cordoba-Rodriguez R; Koti K; Rothmann M; Men AY; Zhao H; Hughes M; Keegan P; Weiss KD; Pazdur R

        *18316547*

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    Clin Cancer Res

    1296 5.14 2008