A month after ImClone Systems Inc. and partner Bristol-Myers Squibb Co. said they would take a second try at the biologics license application for the troubled anticancer drug Erbitux in the second half of this year, the overseas partner - Merck KGaA - said it has filed for marketing clearance in Europe.
Darmstadt, Germany-based Merck is asking for approval to market Erbitux (cetuximab) for irinotecan-refractory metastatic colorectal cancer, the indication for which the drug showed promise in a trial with 329 patients.
Company officials could not be reached for comment.
Data from the Merck trial were disclosed at the American Society of Clinical Oncology meeting in Chicago from the study, called Trial 007, in 329 patients with irinotecan-refractory colorectal cancer that expressed the epidermal growth factor receptor. Merck said Erbitux in combination with irinotecan slowed progression of the disease by more than four months, shrinking tumors by 50 percent or more in 22.9 percent of patients. (See BioWorld Today, June 3, 2003.)
ImClone and Bristol-Myers, both of New York, have said they will file another BLA for Erbitux in the U.S. in the colorectal cancer indication, but have declined to say officially that it will be based on the Merck data.
ImClone's stock (NASDAQ:IMCLE) closed Monday at $33.03, up 27 cents.