ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has approved Erbitux (Cetuximab) Injection 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. The effectiveness of Erbitux is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux. The companies intend to make Erbitux commercially available to patients within two weeks.

"The approval of Erbitux is a defining moment for ImClone Systems and, more importantly, represents a new option for colon cancer patients," stated Daniel Lynch, CEO of ImClone Systems. "We share this achievement with our partners, Bristol-Myers Squibb and Merck KGaA, and our dedicated employees who worked diligently together and with the FDA to obtain approval for Erbitux. This approval is especially meaningful for patients with metastatic colorectal cancer and their physicians because they now have a first-of-its-kind therapeutic with which to fight this deadly disease."

"Bringing Erbitux to market reaffirms our long-held commitment to deliver innovative oncology medicines to patients in need," said Peter Dolan, CEO, Bristol-Myers Squibb. "That commitment will continue as we proceed with the Erbitux clinical development program, and explore this important new therapy in a range of other types of EGFR-expressing cancers."

"The Colon Cancer Alliance is excited about new therapies that will provide additional treatment options to patients with advanced colon cancer, and Erbitux may make a difference for these patients," said Kevin Lewis, chairman of the Colon Cancer Alliance.

"Cetuximab validates the concept that non-chemotherapeutic molecular drugs are active in the treatment of colorectal cancer," said Howard Hochster, professor of Medicine, New York University School of Medicine. "It adds a new dimension in the treatment of this disease and allows oncologists new options for treating patients that have this disease when irinotecan-based chemotherapy is no longer effective or tolerated."