Company: Eli Lilly, in partnership with Bristol-Myers Squibb
2011 sales: $703.3 million
Developer: ImClone Systems
FDA approvals: EGFR-positive colorectal cancer, 2004; second line in head and neck cancer, 2006; first line in recurrent or metastatic head and neck cancer, 2011
Erbitux may be best known in the general population as the drug that sent Martha Stewart to jail, but elsewhere, people have moved on. Since the insider-trading scandal that roped in the doyenne of domesticity, Erbitux won FDA approval, racked up billions in sales, captured the attention of activist investor Carl Icahn, and sold along with ImClone to Eli Lilly ($LLY), after a failed bid from Erbitux partner Bristol-Myers Squibb ($BMY).
Erbitux's history has another odd blip: In 2009, ImClone (owned by Eli Lilly by then) and marketing partner Bristol-Myers petitioned the FDA to restrict Erbitux use. Drugmakers don't usually request restrictions, but in this case, the label change would exclude a group of patients who wouldn't benefit from the drug anyway. Erbitux works well in patients whose KRAS genes are "wild-type," i.e., unmutated. Those with KRAS mutations don't benefit at all.
The FDA's decision to change Erbitux's label affirmed the KRAS gene as a biomarker for response to anti-EGFR drugs. Now, Merck KGaA, which markets the drug overseas, has asked for approval to sell Erbitux for EGFR-positive lung cancer, and scientists posit that it might be helpful for EGFR-positive brain tumors. Lilly and Bristol-Myers, on the other hand, have given up on their bid for lung cancer approval after the FDA issued a complete response letter last month.