FDA helping cancer patients

[martd]

Hopefully this will help some people. .. I'm not sure if this link will work, if not a quick search should find it. I saw it on the news this evening

https://www.fda.gov/news-events/press-a ... s-patients

[Pyro70]

Hopefully this will help some people. .. I'm not sure if this link will work, if not a quick search should find it. I saw it on the news this evening

https://www.fda.gov/news-events/press-a ... s-patients

Doubt it will make much difference. The biggest barrier is that Pharma companies just don’t want to release their investigational agents. Sometimes there just isn’t enough available, other times they don’t want to risk bad press, and probably often it’s easier for them to just say no than handle a special request.

[Green Tea]

...Doubt it will make much difference. The biggest barrier is that Pharma companies just don’t want to release their investigational agents. Sometimes there just isn’t enough available, other times they don’t want to risk bad press, and probably often it’s easier for them to just say no than handle a special request.

Based on what I have heard, I would agree with Pyro70. Although the FDA may give its support to this idea, it is the Pharma company itself that has the final say.

Just to give an example, the Amgen investigational product AMG 510, which made sensational news headlines just yesterday, is only in Phase 1 clinical trials right now and currently unlikely to meet Amgen's own published criteria for Expanded Access:

https://www.amgen.com/responsibility/access-to-medicine/access-to-investigational-medicines/

In my opinion, there are several valid reasons listed in the link above that could be used to justify denial of access. For one, they don't have enough evidence right now to establish a safe dosing range.

AMG 510 is the KRAS mutation agent that is under investigation in the Phase 1 clinical trial below.

https://clinicaltrials.gov/ct2/show/NCT03600883

[martd]

I'm sure this won't help now, especially on a wide scale. But you never know, It could be helpful gaining access alot quicker to the next big breakthrough, and maybe that could speed the trial process along also.

[WarriorSpouse]

Thank you for sharing Martd!

I am happy to see this and expect things that have been recently successful to some, such as Keytruda, being available to many outside of the current norm, hopefully.

Drug companies have a due diligence requirement to sell and distribute things that will help and not harm patients. The fact that the FDA has opened up trials beyond their deadlines gets one party out of the way if a patient is running out of options. There is no magic bullet for cancer. It is unique to each patient and the drugs are tools to combat this uniqueness. This is good news even though some here are skeptical. All FDA approved drugs start somewhere. I am appreciative to "big pharma" for what is currently in use and approved, and with the hope of more good things to come.

Good Science is our friend and not our enemy.
Thanks again!
WS