NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

It's a fact that cancer drugs frequently end up in the NCCN guidelines as recommended treatments for indications other than those for which they were approved. It happens.
Probably because nearly all the NCCN writers receive some form of remuneration from a pharma company or companies. And if the drug is recommended in NCCN, it becomes de facto SOC. And generally gets Medicare / Medicaid coverage.
I'm not suggesting that L could suddenly be widely used for a range of operable cancers, because it couldn't.
But it might be approved for ndGBM, yet end up also being used quite widely for recurrent GBM as well. That sort of off-label use is not much of a stretch at all.

Not that this sort of thing is necessarily good per se...
A point made by Vinay Prasad:-

Prasad: On a single day in March 2016, we froze the entire FDA drug approval list, and we gathered the entire NCCN 4,000-page document and froze it, as well. We compared these two documents and, in the month that followed, we painstakingly compared every time a drug was mentioned and how many times it was recommended by NCCN.



Q: What did you find?

Prasad: The first thing we found was that FDA had approved these new drugs for nearly 70 indications. Then we saw that every single indication the FDA had approved the drug for was in the NCCN document. It missed nothing. In addition, NCCN recommended another 40 or so indications for which these therapies were not FDA approved. We then asked what the evidence was for those 40 or so additional purposes. In most cases, NCCN offered no evidence. In some cases, the evidence was very weak and came from uncontrolled clinical studies.



Q: Did your findings surprise you?

Prasad: We were surprised that NCCN was recommending these drugs so often beyond the approved uses, and we were surprised that the evidence cited was poor, or that evidence was not cited at all. In the United States, we have a system in which officials are stating they are going to pay for all of these cancer drugs that are recommended by experts. Those experts are going to be recommending them beyond what they have been approved for and they are not going to tell you the evidence that they are citing to recommend them, or there is no good evidence, and you have to pay for them once they recommend it. The other thing that serves as sort of a backdrop for this is that many of the experts on the panel have financial ties to drug makers. When putting all of this together, we have to ask ourselves if this is the optimal system. The whole picture is what is concerning. There is the potential for bias here.

https://www.healio.com/news/hematology-oncology/20180607/researchers-offlabel-cancer-treatment-recommendations-often-based-on-weak-evidence