NEW YORK--(BUSINESS WIRE)--ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, a supplemental biologics license application (sBLA) for ERBITUX® (Cetuximab). With this application, the companies seek to include evidence of improved overall survival in the product labeling for ERBITUX in the third-line treatment of patients with metastatic colorectal cancer (mCRC). The Companies also announced that the ERBITUX sBLA has been granted a priority review. Based on the priority review, the likely FDA action date for the sBLA is early October. If the sBLA is approved, ERBITUX would be the only biologic therapy to demonstrate overall survival as a single agent in patients with metastatic colorectal cancer.
