Added indication for Bristol-Myers' Erbitux approved by FDA

The US Food and Drug Administration yesterday approved US drug major Bristol-Meyers Squibb’s (NYSE: BMY) cancer drug Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.

Erbitux, which is marketed in the USA by B-MS under license from Eli Lilly as a result of the latter’s acquisition of the drug’s developer ImClone in 2008, was first approved by the FDA in 2004 to treat epidermal growth factor receptor (EGFR)-positive late-stage colon cancer after patients stopped responding to chemotherapy. The treatment can be used alone or in combination with chemotherapy.

The product, which is sold by Germany’s Merck KGaA outside the USA, generated sales of $662 million for B-MS last year. Merck received approval for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck from the European Commission nearly three years ago (The Pharma Letter December 8, 2008).