Today’s Wall Street Journal (8-2-07) had a front-page piece entitled Burden of Proof: Cancer Drug Fails, So Maker Tries New Pitch. Geeta Anand of the Wall Street Journal wrote it.
The story is about Garo Armen and the biotech company, Antigenics Inc., which he founded 12 years ago and at a cost of 300 million dollars. Antigenics has been developing a cancer vaccine for Kidney Cancer. Unfortunately, their clinical trial had failed; the treatment arm of the trial did not demonstrate a statistically significant reduction in recurrences over the placebo arm. The results showed only a slight trend in favor of the vaccine, not an adequate difference to meet the high standards of the FDA to prove efficacy.
However, when they took a retrospective look at their data they found that in a sub-group of 361 patients where the tumor had not yet penetrated the veins they did in fact have a statistically significant difference in the rate of recurrence of their kidney cancer. Those individuals who received the vaccine lived an average of 4.2 years without a recurrence as opposed to the placebo group who only lived an average of 2.5 years without a recurrence!
So what has the FDA’s response to this new data? Sadly, but predictably, they told Antigenics that they thought the data was encouraging, but they were insistent that there be a new clinical “confirmatory trial” Antigenics has told the FDA that they no longer had the financial resources to run a new trial and that a new trial would take five years to complete.
Does this sound familiar? It sounds just like the treatments I have been writing about, Provenge and Satraplatin. The FDA has again strangled the development of a new drug to help cancer patients. Here, we have a potential new treatment for preventing the recurrence of kidney cancer, a lethal cancer when it does recur. Nevertheless, the FDA, in its wisdom, has blocked this treatment along with the four other drugs this year.
Dr. Robert Temple, Director of the Office of Medical Policy of the FDA, has said, “If someone uses a vaccine that doesn’t work, they will be forgoing something else.” This is an absurd statement, as we do not have anything else to take. Dr. Temple, When I become hormone refractory and have failed Taxotere, what other drugs can I take? Dr. Temple, please tell me what else I can take that might prevent my kidney cancer from recurring?
Antigenics has decided to take their drug to the international community. They have begun to negotiate with the Russian regulators who have been very receptive and positive. I guess that those of us with kidney cancer who have received primary treatment will soon be taking vacations to Russia. I do have to say that St. Petersburg is one of the most beautiful cities I have ever visited. I might have to return even sooner then I would have ever guessed.
I am waiting to hear where I will have to travel to get my Provenge and Satraplatin. I do have many airline miles to use, so off I will go.
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Joel T Nowak MA, MSW