Avastin - $2.66 billion


2011 sales: $2.66 billion
Developer: Genentech
FDA approvals: Metastatic colorectal cancer, 2004; non-small cell lung cancer, 2006; breast cancer, 2008 (revoked in 2011); kidney cancer, 2009; brain cancer, 2009

Avastin has attracted a lot of attention over the past few years, and not always for reasons Genentech would welcome. Its use as a breast cancer treatment, approved by the FDA under its fast-track program, came into question when the FDA released data from follow-up studies. The agency moved to pull that indication from Avastin's label, and the ensuing controversy grew until an FDA advisory panel meeting erupted with emotional testimony from patients, doctors, scientists and advocacy groups on both sides of the fence. The FDA did cancel that approval late last year, but doctors can still prescribe it off-label.

Meanwhile, Avastin's success at another use--wet age-related macular degeneration--created problems for its sister drug Lucentis. That injection was developed from the same parent as Avastin, modified for use specifically in the eye. But eye doctors determined that Avastin could treat wet AMD, and at a much smaller price. The Avastin vs. Lucentis debate prompted the National Eye Institute to fund a head-to-head study, which recently found that the results were more or less comparable, but Avastin came with more side effects, some of them serious. So, the controversy continues.

Avastin - $2.66 billion