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Prostate Cancer Vaccine May Get FDA Approval
Date:4/27/2010

moved from the patient, the cells are treated with the drug and placed back into the patient. These treated cells then cause an immune response, which in turn kills cancer cells, while leaving normal cells unharmed.

Provenge was developed by Seattle-based Dendreon Corp., which conducted initial studies among men with advanced prostate cancer who had already failed standard hormone treatment. Among these men, the vaccine extended life by an average of 4.5 months, although some patients saw their lives extended by two to three years. The only side effects were mild flu-like symptoms, according to the study results.

In 2007, an FDA advisory panel recommended that the agency approve Provenge, but the FDA said more data was needed before it would approve the drug.

If the drug is approved, its use will most likely be limited to men with advanced prostate cancer. And at an expected cost of $75,000, it won't be inexpensive.

Dr. Mark Soloway, professor and chair of urology at the University of Miami Miller School of Medicine, said that "we certainly need the opportunity for our patients to have alternatives."

The big question, according to Soloway, is when do you use Provenge? Whether it should be used before chemotherapy or hormone therapy isn't clear, he said.

"There are problems with Provenge," Soloway said. "One is that it's very cumbersome, because patients have to provide their white cells, and I think that's on a regular basis. And two, it's likely to be very expensive."

Soloway agreed that Provenge might also be useful in earlier-stage prostate cancer, but studies are needed to prove that.

However, "once it's approved it's on the market and with proper informed consent you can use it for localized [early stage] prostate cancer. Whether insurance companies will pay for it is also not known," Soloway said.

Other new drugs to treat prostate cancer, such as Abiraterone, which pre
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