ImClone Systems Incorporated announced that that the Food and Drug Administration (FDA) has accepted for filing and review the company's Chemistry, Manufacturing and Controls (CMC) supplemental Biologics License Application (sBLA) for licensure of its BB36 manufacturing facility.
Based on Prescription Drug User Fee Act (PDUFA) guidelines, the action date for the CMC sBLA is June 18, 2004. Subject to licensure of BB36 within the PDUFA timetable, ImClone Systems and Bristol-Myers Squibb continue to believe that they can meet full commercial demand for Erbitux (Cetuximab) on an ongoing basis.
On February 12, 2004, the FDA approved Erbitux for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.
In June 2002, the FDA authorized Erbitux manufactured at BB36 for investigational use, and the companies will continue to utilize this supply in ongoing and planned clinical trials. In addition, Swissmedic approved Erbitux manufactured at BB36 for commercial use in Switzerland in December 2003, in addition to a European manufacturing site.