Amgen and Abgenix have won fast-track approval for their antibody cancer drug, panitumumab, to treat patients with advanced colorectal cancer who have failed on standard chemotherapy.
Panitumumab is directed against the epidermal growth factor receptor, which has been implicated in various tumours. It is the first fully-human antibody to inhibit EGFr, say the firms, which hope this will result in less potential for allergic and immune system reactions. It is being tested as both a monotherapy and combination therapy in lung and kidney cancer – amongst others – and is currently in a pivotal study evaluating its use as a third-line monotherapy in colorectal cancer patients.
Amgen and Abgenix now hope to file a first regulatory submission by the end of the year, with the fast-track designation allowing it to complete the filing in the first quarter of 2006. The US Food and Drug Administration, it says, 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.”