FLEX: Erbitux Boosts Survival Five Weeks

There was no benefit recorded for Erbitux with median progression free survival, however, with both arms of the study reaching 4.8 months.

New, Larger Markets

U.S. sales of Erbitux rose 6% to $692 million in 2007, primarily coming from approved uses in colon cancer and head and neck cancer. As an approved drug, doctors are free to prescribe Erbitux to their lung cancer patients today. ImClone and Bristol-Myers hope that the FLEX data, presented with much fanfare at the ASCO meeting, convinces doctors to do just that.

Estimates vary, but lung cancer could be a $500 million-plus revenue opportunity in the U.S. for ImClone and Bristol-Myers Squibb.

Genentech's (DNA Quote) cancer drug Avastin is already a major player in the non-small cell lung cancer treatment market. The drug received FDA approval based on a study in which patients taking Avastin plus chemo reported overall survival of 12.3 months compared to survival of 10.3 months in patients given chemo alone.

As discussed previously, Avastin and Erbitux won't necessarily compete for lung cancer patients because Avastin cannot be used in about 50% of patients due to safety concerns.

ImClone CEO John Johnson, in an interview Friday, says that once Erbitux is approved in lung cancer, the company's sales force will focus on these "Avastin ineligible" lung cancer patients, as well as other patient groups within the FLEX study that derived the most benefit from the drug.

One of the largest and most difficult to treat subtypes of lung cancer is squamous cell carcinoma. Avastin isn't used in these patients, but Erbitux likely will based on data from the FLEX study.