Provenge Doc: FDA Has All the Data It Needs

"Four months of survival including crossover probably means that the survival benefit may be even higher, with no significant toxicity. While I would have liked to see some data showing Provenge improving quality of life, if the drug is approved and paid for, there are not going to be a lot of reasons not to use it," he said.

By crossover, Reiter is referring to a rule in the study that allowed patients in the control arm to receive a frozen form of Provenge once their prostate cancer progressed. This set a higher bar for Provegne to show a survival benefit.

While Provenge's survival benefit was robust, the drug did not shrink tumors or stop them from growing. The study was also not designed to measure whether patients enjoyed an improved quality of life.

Penson, however, says the drug's clean safety profile and ease of administration makes patients feel better.

"I don't have hard quality-of-life data, but in my gut after treating patients, I do believe that Provenge improves quality of life," he says. "A patient can get this drug on a Friday and play golf on Saturday. That's not an exaggeration; that's a fact."