Quote: "I realize that this is an extraordinarily complex and controversial issue, but given the stratospheric cost and the low median survival benefit, I just can't see it."
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Maybe you will see "it" a bit better when you realize that Provenge is one of only four drugs ever approved by the FDA to extend median lives by 4 months or more for any form of metastatic cancer. The three other drugs that have ever shown a 4 month or better survival benefit in any form of metastatic cancer were: 1) Avastin, 2) Herceptin, and 3) Altima. Please note that survival is the FDA's "gold standard" for measuring cancer trial outcomes (and is not subject to the high noise or ambiguity of results shown by other clinical outcomes like progression for example). Of course, since this is a median figure, some patients do much better than 4 months. Also, there was a 70% placebo cross-over rate to active treatment, so it is very likely that the demonstrated survival benefit was mutted. The treatment benefit is accomplished with a highly favorable side effect profile and the entire course of therapy is a short 1 month, thereby freeing patients to pursue other courses of treatment. Finally, CMS left the door wide open today to expand the reimbursed Provenge label or patient population should future robust evidence develop.
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