Hi Mr Romper,I don’t think so. In general people are very...

Hi Mr Romper,
I don’t think so. In general people are very conservative in this area. Ethical approval would be harder to use a treatment that does not have comprehensive evidence of efficacy when there are well established treatment options available.

In my opinion what is more likely to happen is that firstly our treatment is approved for bile duct cancer in patients who have failed other treatment options.

Once this is approved and it is known that the drug is safe in humans it can potentially be used for other cancers. This could happen in the following way.

A patient with a diffferent type of cancer that has failed other treatment options may be still looking for further options. An oncologist may be aware of the science and that in theory it should work across multiple cancer types. They may also be aware of the early trials. They can then have a conversation with the patient saying as we have exhausted all other treatment options there is another possibility. It is not well researched in your particular cancer type but there is some low level evidence it could work in your case. In addition the adverse reactions/ side effecrs are generally mild. Would you like to try this?

If the treatment is effective or if it is not some (not all) oncologists may write this up as a case report. To communicate with other oncologists so they feel more comfortable using it. If an oncologist collects a few patients they may provide a case series again increasing the evidence base.

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The approval for one limited indication may allow expansion into other cancer types. Moving up the treatment paradigm to become a second of firsr line drug will take more time and building the case is harder but I assume IMU will run those trials in good time. They may also choose to pick off some other cancers they think are worthwhile as a 3rd line treatment by formally running those trials.

The bile duct cancer gives IMU a window into the clinical setting. I think it is a very smart move by them to narrow their focus and get the first indication ticked off ASAP.