Beyond the data, this approval is notable for the speed from FDA acceptance of their new drug application (NDA) to FDA approval - just over a month. Compare this to the typical 8-12 month timelines we've historically seen for priority and standard reviews, respectively. This was enabled by the FDA's CNPV Pilot Program [0]
Previous discussion following the data presentation at ASCO: https://news.ycombinator.com/item?id=48517199
[0] https://www.fda.gov/industry/commissioners-national-priority...
Seriously? So for example the covid vaccine should have been approved in 1 month based on the crisis response or because mRNA approach is transformative, or if it could be made in the US. I feel so much safer knowing a reckless FDA won't be a problem now.
I’m trying to understand your point. This drug is for people with metastasized cancer. I’m comfortable with fast tracking it, because what’s exactly the harm of letting desperate people try something that seems likely to help a lot?
Also, the risk profile is sort of the inverse of a covid vaccine where everyone was supposed to take it.
The FDA article lists 5 reasons the pilot of the pilot is only for the non controversial one that is not even listed in a way that maximizes its risk/benefit requirements.
Comparing the acceleration of FDA approvals for non-contagious terminal diseases like PDAC to development of COVID vaccines is flawed on so many levels. You make it sound as though this was just cooked up in some desert meth lab RV over a weekend, and the FDA just rubber-stamped after a cursory glance at the data. The Phase 1/2 study first exploring daraxonrasib (RMC-6236) was posted on clinicaltrials.gov in May 2022; this trial enrolled 754 patients [0]. The RASolute 302 study this approval is based on was first posted to clinicaltrials.gov in October 2024; this trial enrolled 500 patients [1]. Nevermind the years of preclinical discovery and translational work that had to precede human studies.
As you can see from the control arm showing 6.7mo of survival on standard of care chemotherapy, these patients have a very poor prognosis. Is this a cure? No. Does it buy time to see your child graduate, get married, or give birth? Quite possibly.
If you ever have the opportunity to work behind the scenes within the pharma industry and/or FDA, you'd be astonished that anything ever gets approved with all the red tape and complexity along the way. Medicine is not software - it operates within the black box of human biology which is incredibly nuanced from patient to patient.
Like many who have shared personal stories in this thread, I've lost friends to PDAC. It is a terrible disease often driven by a mutated oncogene (KRAS). Many cancers have KRAS-driven subtypes (lung, colorectal, low-grade serous ovarian, etc). The clinical platform and pipeline at RevMed has potential to address many other cancers. They have next-gen RAS agents that could be even more impactful.
For those curious, RevMed posted a solid summary of the approval on their IR site [2]
[0] https://clinicaltrials.gov/study/NCT05379985?tab=researcher [1] https://clinicaltrials.gov/study/NCT06625320?tab=researcher [2]https://ir.revmed.com/static-files/0f7e4612-ad39-4c87-b266-8...
Good post but the whole "buy time to see your child graduate, get married or give birth" trope is quite frankly very annoying.
Older people have more going on, and more reasons to live, than whatever the next generations are up to. Even if we have children.
I had curative (hopefully, presumably) kidney cancer surgery 11 years ago. So far I've enjoyed travelling, socializing, working, coding, chess and other hobbies in the extra time I've been granted and I hope for decades more time to enjoy life. I don't have children. never aspired to it.
Sorry for the rant!
I have kids.
I also travel, socialize, work, code, play video games, solve puzzles, etc. Love all that shit.
I'd be sad to "miss" some novels, or to never see the Ocarina remake, etc. Or just the time I spend piddling around with things.
But I think if I was about to die and an advance bought me a few months of moderate quality life, it'd mostly be about seeing my kids cross milestones. I don't imagine I'd spend nearly as much time cranking through those things.
Understood. No doubt I would be similarly inclined if I'd gone down that path in life. My beef is that I feel this is a trope that gets rolled out without question, and it doesn't even bother paying lip service to the diversity of human experience.
I feel similarly whenever I hear about someone expressing empathy with someone, but apparently only after realizing they are someone's daughter/brother/sister/mother whatever type of relative. What's that about? I feel empathy for any innocent victim, they're human, they're living a life, maybe a very enjoyable life even if they don't have a single relative.
It's a trope for a reason. Having kids does shit to your brain and breaks it in a bunch of ways you cannot anticipate. For better and for worse.
Read the stuff you link to. The FDA article on their criteria says nothing about it needing to be for terminal cancer (is high cholesterol terminal?) Make anthrax hemroid creme in the US and it meets the criteria of the pilot. You should stop falling for scams like being presented with a first result of a pilot that is an improvement and not reading that the pilot itself was created for the other 4 scam cases.