FDA News

FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer

(June 11, 2007)-- ImClone Systems and Bristol-Myers Squibb Company 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.

The sBLA, which is based on results from a large, randomized, multicenter, Phase III trial, seeks to update the monotherapy indication to include patients with EGFR-expressing mCRC whose disease has progressed following, or who were not candidates to receive, irinotecan- or oxaliplatin-based chemotherapy. The sBLA also seeks to include data on overall survival relative to best supportive care - considered to be all approved palliative therapies designed to alleviate pain and treat other effects caused by advanced colorectal cancer in this patient population.

Currently, in mCRC, ERBITUX is indicated as a monotherapy for EGFR-expressing mCRC patients who are intolerant to irinotecan-based therapy. ERBITUX is also approved in combination for the treatment of EGFR-expressing, mCRC in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy; this combination indication would remain unchanged. These indications were approved based on objective response rates.

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