Deconstructing Bexxar

The story of Bexxar is one of a bet that the original corporate sponsor could ignore FDA's advice on how to run a pivotal trial, provide a piecemeal regulatory package, and still win marketing approval.

Following last week's positive FDA advisory panel meeting, it looks like the radioimmunotherapy will be approved for non-Hodgkin's lymphoma patients who are refractory to chemotherapy or Rituxan. But one still could argue that the bet was lost: The original sponsor, Coulter Pharmaceutical Inc., was sold to Corixa Corp. after the FDA rejected the original BLA submission in 1999. Meanwhile, the regulatory process has taken two-and-a-half years to date, and it probably never will be known how much it cost investors in terms of time and money...