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Home » FDA GRANTS FAST-TRACK DESIGNATION FOR PANITUMUMAB
FDA GRANTS FAST-TRACK DESIGNATION FOR PANITUMUMAB
August 2, 2005
Amgen and Abgenix have announced that the FDA has granted fast-track designation
for panitumumab, an experimental fully human monoclonal antibody directed against
the epidermal growth factor receptor (EGFr), for patients with metastatic colorectal
cancer who have failed standard chemotherapy treatment.
In light of this fast track designation, Amgen and Abgenix are working toward
initiating the submission of the biologics license application (BLA) for panitumumab
in patients who have failed prior standard chemotherapy, including irinotecan
and oxaliplatin, by the end of 2005. The completed submission of the BLA could
extend into the first quarter of 2006, depending on timing and outcome of clinical
data. FDA has previously indicated that data from one pivotal trial, once completed,
could be acceptable with additional data from other pending studies to support
a submission for marketing approval in the U.S.
Panitumumab is an investigational product in a novel class of targeted cancer
treatments called epidermal growth factor receptor (EGFr) inhibitors. Panitumumab
(formerly ABX-EGF) is the first fully human monoclonal antibody directed against
EGFr and is being evaluated as both a monotherapy and in combination with other
agents for the treatment of various types of cancer.
KEYWORDS Drug Pipeline Alert
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