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FDA approves first in class targeted therapy for metastatic pancreatic cancer

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

#21

Post by botro »

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 hospital since; switching between ICU and general care. His abdomen fills up with fluid, around 6 liters every 5 days, draining the fluid plunges his blood pressure and he end up in ICU. They supply Albumin until blood pressure stabilizes and send him back to general. Only after the first chemo session the oncologists have stopped the treatment saying he's no longer eligible for chemo because of his over all health.

We're lucky enough to live an hour away from Johns Hopkins (though that's not the hospital he's currently at) and had an appointment scheduled but had to cancel since he's unable to walk.

The oncologist mentioned that daraxonrasib was available as an option when he first started chemo, but said he would only be eligible for it after trying chemo, so we know the drug is available.

Are there any tips from HN on how we can approach getting this medicine for my father in law?

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

#22

Post by seizethecheese »

2OEH8eoCRo0 wrote: post #17
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.

Sorry for your loss. My mémère passed recently from it. It's a terrible illness and I'm glad that others can have more time.

mémère Is French for grandmother, for other readers, since I looked it up.

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

#23

Post by octaane »

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/

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

#24

Post by octaane »

matthewsjess wrote: post #13

Fantastic news. Research on Metastatic treatments has been underfunded. Yet immunotherapy and other treatments are showing amazing promise.

I would argue that it is not underfunded, as most big pharma companies with oncology products have dumped enormous amounts of money into research pipelines and clinical trials. Immunotherapies like nivolumab or ipilimumab or pembrolizumab have varying (but often very decent) efficacy data for metastatic disease across tumor types.

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

#25

Post by silver_sun »

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…

Revolution Medicines has an Expanded access program: https://www.revmed.com/expanded-access-policy/

I would suggest you have your physician submit a Expanded access request immediately, because the same page says that they will close this program after FDA approval as they transition to commercial use, but the timeline for that is unclear.

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

#26

Post by norbertsboat »

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.

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

#27

Post by pfdietz »

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.

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

#28

Post by pfdietz »

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.

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

#29

Post by seizethecheese »

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.

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.

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

#30

Post by greenowl »

jrapdx3 wrote: post #8
datakan wrote: post #2

My dad passed in 2020 from pancreatic cancer. He'd been to the doctor several times complaining about issues and all they would do is send him home with laxatives. Eventually it got bad enough my mom ran him to the ER when they found the cancer which had progressed into its final stages already. He was dead less than a month later. Similar story with a guy I worked with. He went home sick one day. A few days later ou…

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, cause severe patient anxiety and healthcare burden, and result in over-treatment.

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

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