The application seeks approval for use of Erbitux in combination with radiation for locally or regionally advanced head and neck cancer, and as monotherapy in patients with recurrent and/or metastatic disease where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate.
The FDA grants priority review to biologics that potentially offer a significant therapeutic advance over existing therapies for serious or life-threatening diseases. Based on the priority review designation, the FDA has six months from the submission date of August 30, 2005, to take action on the filing.
In February 2004, the FDA approved Erbitux for use in the US in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer.