Anyone else on Daraxonrasib (RMC-6236)?

@mcoplien My wife Trudi receives treatments at Mass General Hospital. She has been through both main chemo lines that now are no longer effective. She has been accepted for early access to daraxonrasib, but the start date to receive the pill is not secure. It depends on Rev Med delivering them to the queue of Mass General patients waiting for the pills to arrive. She has received from her oncologist the various medications to deal with the most common side effects, particularly rash and diarreah. (sp?). Meanwhile, her cancer marker continues to rise. It certainly is a waiting game. Thanks for getting back to me, and good luck with Mike's treatment.

@ljojimo Unfortunately, a few folks here are waiting on Rev Med to distribute the medication. Please let us know how things progress, so we can all learn from each other's process. Thanks.

My name is Lori. My husband is battling pancreatic cancer. My question is how can you get that new drug that is not FDA Apptoved yet but shows promising help with the cancer. His doctor said he filled out the paperwork but it has been over a month. He needs to be on some kind of treatment.

@drewgrebe Here is the process from the manufacturers website: https://www.revmed.com/expanded-access-policy/
Here is a link to a current conversation on Connect with experiences of others on daraxonrasib and those having issues getting the new treatment as well: https://connect.mayoclinic.org/discussion/daraxonrasib/
Are you running into the same issues?

Daraxonrasib is one of the most exciting new developments in pancreatic cancer, so I can understand why your oncologist is optimistic. If your husband is a good candidate based on his tumor's molecular profile, I hope it works very well for him.

The treatment break can definitely be unsettling, but sometimes it's intentional. Your oncologist may want him to recover from previous therapy before starting the new medication, or it may simply be part of the clinical or prescribing process while insurance approval is being completed. If you're concerned, don't hesitate to ask why the pause is necessary and whether they expect it to affect his treatment.

As for the rash, many patients on KRAS inhibitors develop skin reactions, but there are effective ways to manage them. Many oncologists start moisturizers early and may prescribe topical steroids or oral antibiotics if a rash develops. It's important to report any skin changes early rather than waiting until they become severe.

If he hasn't already had one, you might also ask whether his team plans to follow circulating tumor DNA (ctDNA) with a blood test such as Guardant360 or Signatera, in addition to CT scans and CA 19-9. These tests aren't appropriate for every patient, but they can sometimes provide additional information about how the cancer is responding.

I hope the approval comes through quickly and that daraxonrasib is everything we hope it will be. Please keep us posted—many of us are watching these new KRAS-targeted therapies with great interest.

Patients going through one of these sites for daraxonrasib are experiencing varying approval times between 48 hours and 4 weeks.
https://clinicaltrials.gov/study/NCT07573215

Yes the wait is hard. We are in Madison WI. The Cancer Center here first had to apply to be part of the expanded access program (EAP) which I think they did in May. In June Mike's doctor told him it would be a few weeks or months (they were not certain). In July Mike's cancer has spread to 3 organs, the old chemo is not working, he has not had chemo since 6/18. On July 9 the doctor (who had already submitted Mike's name) said he would reach out to the research team, hoping Mike could start in a couple weeks. The research team reached out after 2 weeks, another week of tests and interviews, if he is found to be "eligible" they will order the medication which could take 2 or 3 weeks to get. Sorry but it is a waiting game. Keep reaching out to the doctor for updates or see if there is a Plan B while you wait.

@mcoplien thank you for your reply. It has helped me tremendously.

My husband d is waiting for this drug too. I was
Blaming g his doctor for him not getti getting it. But I am finding out it takes awhile. The FDA needs to approve this drug if Itnis good. They are Messi g with people lives. Ugh. My prayers for everyone needing this drug.

@mcoplien one of the crucial criteria for the expanded access is cancer progression. If he has KRAS and cancer progression he should be getting the drug more easily. A friend here in CT was approved within a week for an arm of a trial at Yale with the pill and gemabraxane. I would call your nearest hospital that participated in the trials for these last few years and get there ASAP before his cancer progresses any further. You may just be able to have his bloodwork and scans reviewed and get access to the pill sooner or offered a trial. God Bless