In cancer all sorts of products that are approved for a single or limited number of cancers are routinely used off label. In my case of leukemia, many of the treatment I used, including the one I've been on for years after stem cells has never been tried clinically for my specific form of leukemia. I believe it's pretty much accepted as a SOC product for it, yet it hasn't been through clinical trials. Why not? Because it doesn't have to to be accepted by the medical community worldwide.
To begin with during DCVax-L's trial GBM was redefined, some of the people in the trial would no longer be considered as having GBM. Do you think approval will only be for GBM, I believe it will go further than that, and it should be used in brain cancer in general, even if that's not what the label says. I really believe the label should be for brain cancer, but time will tell what it says.
We know that under compassionate use people have tried it in other cancers and there is documentation of some very satisfied customers. Do you believe that what was permitted under compassionate use while the vaccine was experimental won't be permitted after it's approved, I strongly believe it will not be the case.
Anecdotal evidence has often been the key to insurance, Medicare, etc. approving the use of products off label. In some cases legal suits dictated that a product should be paid for in spite of no clinical trials. Once insurance fights and loses they rarely continue to fight.
I certainly believe that once NWBO is adequately funded that they'll start to design trials intended to expand the label, but those trials will take years. Off label use and anecdotal evidence will build up well before new trial results are in, if in fact they are positive, use may be authorized and paid for well before clinical trials can be completed.
In my leukemia treatment I was fortunate enough to get a catheter infection half way through 8 courses of chemo that was considered the SOC. Why fortunate, because in my time out of the hospital I met the head of hematology at City of Hope and he agreed that I could be his patient and a candidate for stem cells, simultaneously in conjunction with my oncologist he dropped the additional 4 courses of hospitalized chemo and just continued my treatment on pill chemo which was started during the treatment of the infection.
In many ways DCVax-L could be ideal in combination with existing therapeutics as it has virtually no negative side effects and has been shown in GBM to clearly permit therapeutics that didn't work without it to be very effective with it. No telling how many similar synergies will be found as DCVax-L, and in the future Direct, are tried in other cancers. I believe that the best Oncologists will use SOC treatment while it's working, but if in their opinion up front something is better, they'll begin with that. Most importantly when something isn't working, they'll find something else and keep trying as long as they believe there is a chance, and the patient is willing to continue the fight.
Sadly I'm missing friends who finally decided that they no longer wished to continue the fight, I think it's a decision that we each have the right to make when medically we deem our quality of life not worth living. I certainly respect their decision, but can't help missing them. I believe that once it's back in production, DCVax-Direct ought to be a choice for anyone with an inoperable tumor that clearly isn't responding to current therapeutics, or even to boost the response if it is.
Gary
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