Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

FDA approves first in class targeted therapy for metastatic pancreatic cancer

fda.gov

Post reply on HN
Print view View original

31–40 of 76 posts

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#31

Post by norbertsboat »

seizethecheese wrote: post #29
norbertsboat wrote: post #26

Earlier quoted context omitted.

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.

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#32

Post by epistasis »

pfdietz wrote: post #28
epistasis wrote: post #4

Metastatic pancreatic cancer is the first indication for this class of RAS-inhibitor, but it certainly won't be the last, and it seems certain that there will be many many more cancers where this drug gets approved. There are mutations to activate KRAS in a substantial fraction of cancers across many organs, and but it's been such a hard protein to target with a drug that even decades ago I was told it was "undruggab…

One downer about this drug is the absolutely horrific side effects, like "your skin feels like you've been dipped in acid" kind of horrific. Still, pancreatic cancer is just that bad, so maybe that's worthwhile.

Yes, the side effects were very extreme. As time goes on, I'm optimistic that management of the side effects will improve, and outcomes will improve along with that too. Much like chemotherapy, this type of treatment affects a lot of non-cancer cells too.

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#33

Post by jghn »

pfdietz wrote: post #27
jmcharnes wrote: post #11

My sister was diagnosed with pancreatic cancer in October (48 years old) and died in June from it. I'm glad to see a drug like this developed for people suffering from pancreatic cancer. I don't wish what my sister went through on anyone. Damn if I don't wish it had come a little sooner.

My mother died of it less than two weeks after the diagnosis was confirmed by biopsy. On the other hand, I knew a guy at work who survived more than five years with it; this was so unusual there was an advocacy group that used him as a kind of poster child of hope. He looked just terrible though.

a lot depends on the exact diagnosis, both stage and the specific kind of pancreatic cancer

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#34

Post by freediddy »

jmcharnes wrote: post #11

My sister was diagnosed with pancreatic cancer in October (48 years old) and died in June from it. I'm glad to see a drug like this developed for people suffering from pancreatic cancer. I don't wish what my sister went through on anyone. Damn if I don't wish it had come a little sooner.

I'm very sorry for your sister's death. My friend's dad was diagnosed with pancreatic cancer out of the blue and died within 6 weeks. It terrifies the fuck out of me because there's nothing you can do to detect it or fight it. Hopefully this drug helps people get cured of it.

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#35

Post by freediddy »

HedonicEscal8r wrote: post #16
yepyeppers wrote: post #12

Earlier quoted context omitted.

That’s a generalization, pancreatic cancer is often extremely lethal, depending on the type and case the survival rate can be as or more grim than glioma. Bowel and urinary cancers including kidney cancer are often very treatable and survivable when discovered due to symptoms. I don’t think it’s helpful to group all abdominal cancers as being uniquely or especially bad or late discovered. Likewise for the particularl…

It can be disappointing to see that even a successful drug, like this one, is "only" extending life expectancy from 6.7 months to 13.2. But this is what the first steps towards a cure look like. Childhood leukemia used to be overwhelmingly fatal, and early chemotherapy trials also only managed a couple months of remission. Researchers were even criticized for subjecting patients to harsh side effects to no apparent b…

Moderna is testing an mRNA vaccine that might be useful against bladder and kidney cancers. Hopefully the same technology can be applied to pancreatic and liver cancers. Fingers crossed.

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#36

Post by mwigdahl »

jmcharnes wrote: post #11

My sister was diagnosed with pancreatic cancer in October (48 years old) and died in June from it. I'm glad to see a drug like this developed for people suffering from pancreatic cancer. I don't wish what my sister went through on anyone. Damn if I don't wish it had come a little sooner.

My father-in-law died of pancreatic cancer three months after diagnosis.

It is a horrible disease, not least of which because it’s difficult to diagnose. By the time they get a clear bead on it, in many cases, it’s stage four and already ravaging your system.

I’m very sorry for you and your family’s loss. And I hope this drug makes it so a lot fewer people have to go through this in the future.

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#37

Post by freediddy »

greenowl wrote: post #30
jrapdx3 wrote: post #8

Earlier quoted context omitted.

FWIW it's commonly the case with cancers of abdominal organs: stomach, pancreas, liver, kidney, etc. These cancers are frequently not diagnosed until at an advanced stage. Symptoms tend to be nonspecific, overlap with ubiquitous conditions like constipation, gastritis. A goal of research is improving early detection of these cancers but it's an uphill battle. It's difficult to increase providers' "index of suspicion"…

We are able to early detect these cancers right now with routine targeted imaging. Perhaps we should be working to solve or improve on the drawbacks associated with doing this, some of which are: CT scans emit ionizing radiation. MRI contrast can buildup and be retained in the body over repeated administrations. The scans can produce false positives, surface benign abnormalities which result in a wild goose chase, ca…

> And of course doing this on a whole population level is not cost or time effective.

It will never be cost or time effective if we never try. I'm paying out of pocket every year for an MRI scan, this was my second year this past year.

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#39

Post by hentrep »

norbertsboat wrote: post #26
hentrep wrote: post #6

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?i…

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.

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...

Re: FDA approves first in class targeted therapy for metastatic pancreatic cancer

#40

Post by botro »

octaane wrote: post #23
botro wrote: post #21

My father in law was diagnosed with stage 4 pancreatic cancer that's spread to his lungs about a month ago. This news today raised my wife's hopes immensely and had them immediately doused after hearing the oncologist say that although the drug is approved it will take months before they are able to prescribe it. Father in law started chemo a few weeks ago and his condition deteriorated quickly, he's been at the hosp…

Ask the oncologist directly. Also, try contacting Revolution Medicines directly (the manufacturer), and/or go through their early access page: https://www.revmed.com/expanded-access-policy/

Thank you for sharing, the oncologists are saying that at this point in the diseases progression the same things that disqualify him from getting chemo also disqualify him from this drug. That in his current state it would do more harm.

I hope many others are helped by daraxonrasib, the key factor seems to be how early the cancer is detected, because it is an extremely fast acting disease.

Post reply on HN