Source: www.reuters.com
Author: Ransdell Pierson

ImClone Systems Inc. on Wednesday said it had asked U.S. regulators for permission to market its Erbitux medicine as a first-line treatment for head and neck cancer.

The company’s flagship product, which it sells in partnership with Bristol-Myers Squibb Corp, is already approved to treat colorectal cancer and patients with head and neck cancer who previously had failed to benefit from chemotherapy.

ImClone said it had asked the U.S. Food and Drug Administration to grant its marketing application a priority review, a designation that would ensure an answer from the agency within six months instead of the customary 10-month review period.

The New York-based drugmaker said its application was based on successful results of a late-stage trial involving 442 patients with previously untreated head and neck cancer. The trial showed that Erbitux, when added to current standard platinum-based chemotherapy, significantly increased the overall survival time for patients.

Note:
1. Reporting by Ransdell Pierson, editing by Maureen Bavdek