Warning: Undefined variable $zfal in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 525
Deprecated: str_replace(): Passing null to parameter #3 ($subject) of type array|string is deprecated in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 525
Warning: Undefined variable $sterm in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 530
Warning: Undefined variable $sterm in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 531
Warning: file_get_contents(http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=18316547&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests
in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 445
English Wikipedia
Nephropedia Template TP (
Twit Text
DeepDyve Pubget Overpricing |
lüll 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 RClin Cancer Res 2008[Mar]; 14 (5): 1296-302PURPOSE: 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] |