Erbitux to Be Made Available to Terminally Ill Colon Cancer Patients

The experimental drug Erbitux will be made available to terminally ill colon cancer patients under the U.S. Food and Drug Administration's compassionate use program, ImClone Systems Inc. and marketing partner Bristol-Myers Squibb Co. announced.

The FDA in December 2001 refused to review ImClone's application to market Erbitux, citing faulty clinical trial data. ImClone and Bristol-Myers subsequently have sought permission to begin two large, late-stage trials of Erbitux in combination with other cancer drugs.

Germany's Merck KGaA, which has rights to Erbitux outside of the of the U.S. and Canada, announced on December that preliminary analysis of data from its own late-stage colon cancer trial was encouraging, and said it planned to release results at the annual meeting of the American Society of Clinical Oncology in May.

ImClone and Bristol-Myers said the limited access program will enroll and treat patients with epidermal growth factor receptor (EGFR)-positive colon cancer who are not eligible for current clinical trials and who have failed other treatments.

"We are happy to finally see an expanded access program -- we wish it had been sooner and we wish it were more people," said Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, one of several patient-advocacy groups urging expanded access to Erbitux.

Other Sources: Bristol-Myers Squibb