Amgen announces fast track review for colorectal cancer drug

Amgen, the world’s largest biotechnology firm, has said that the FDA has agreed to offer a priority review for panitumumab, a monoclonal antibody drug which can help treatment for metastatic colorectal cancer.

The FDA’s decision, which means the regulator will take action within six months of the application date, follows the release of the details of the phase II trials that demonstrated the “promise” of the drug in treating advanced thyroid cancer.

Panitumumab targets the epidermal growth factor receptor (EGFr), a type of receptor responsible for the growth of many different cells. However, in cancer cells it can be activated unnecessarily and cause the growth of tumours. Panitumumab inhibits this receptor in an attempt to stop it activating and so halting the growth of a tumour.

In a previous phase III trial, the drug was able to “significantly” improve disease-free survival and disease control.

Marc Peeters, co-ordinator of the digestive oncology unit, University Hospital Ghent and lead study investigator, remarked: “Panitumumab reduced the rate of disease progression by approximately half compared to best supportive care alone in these heavily pre-treated patients.”

“Furthermore, the difference in objective response rates and the proportion of patients with disease stabilisation between panitumumab and best supportive care alone demonstrated the significant activity of this agent,” he added.

Bristol-Myers Squibb’s Uftoral, Roche’s Xeloda, Sanofi-Aventis’ Campto and Merck KGaA’s Erbitux are all examples of drugs currently prescribed for the treatment of metastatic colorectal cancer.

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