success for avastin in europe, page-24

I would doubt any form of corruption was involved ppeter.

nuts, there are a lot of things to consider in this scenario. PFS is and isn't acceptable depending on a plethora of different conditions, and in a lot of scenarios overall survival isn't a tenable end-point, and can often require larger study cohorts and longer follow-up periods in order to obtain statistical significance.

Remember that oncology, particularly with end-stage cancers, is a bit of a difficult area to investigate. If a patient has continued disease progression and tumour resistance to all previously attempted treatments, their oncologist may recommend a drug which is efficacious in other tumours - simply because they have exhausted any other option. This is not too common, but a quick look at the oncology pharmacy database over the past week for the hospital I work at would likely show examples of such use.

With Avastin, its use in metastatic breast cancer now falls under this label (link here). On this topic, on 18th Nov 2011 The FDA Commissioner noted "because FDA does not regulate the practice of medicine, clinicians may continue to prescribe bevacizumab for the treatment of metastatic breast cancer... despite withdrawal of approval for this use."

The same is true even outside of oncology. Avastin itself is a good example of this, with ophthalmologists administering Avastin off-label as a treatment for macular degeneration, because it's vastly cheaper than the similar drug licensed for that purpose (link here).

Off-label drug administration is rather widespread. If you have ever been to see your GP complaining of flu-like symptoms (a cold, runny nose, sore/red throat) and they've given you antibiotics, you would be another example of it. While antibiotics do nothing for viral infections, they do make patients feel better, and because the perception is that drugs take a while to work, they make patients feel properly tended to, and wait it out a day or so (at which point a viral cold usually dissipates naturally). This is only one of several examples of a form of GP-administered placebo. Patients generally feel worse (and dismissed) if they hear "it's just a cold, and I can't actually do anything to help you" from their doctor.

In the end this primarily reflects that, thankfully, doctors almost universally want the best for their patients (both financially and medically). That said, while these practices are completely understandable - and quite difficult to avoid - they are not necessarily an example of best practice.

Back to oncology, the situation is quite different. The patients generally have very little to lose at the point where they are receiving treatments for other cancers off-label, and even if it improves progression free survival and not overall survival, oncologists may administer it anyway - even off-label.

If CAN-003 shows positive results in current (and future) trials in ovarian cancer and gains approval I'd expect the same would happen. I do want to comment that while this is somewhat "the way things are", I don't necessarily agree with these practices...