Drug Doubles Survival Time - Saltikva

I am new to the Pan-Can world and had not heard of this drug. Thank you for the question. It seems quite promising. Hopefully some of the well versed people here will know more.

I am not an expert on clinical trials, so I may be misreading this, but I found this online:
https://classic.clinicaltrials.gov/ct2/show/NCT04589234
It looks to me like this is still in phase 2 trial. If you scroll down to the bottom of the page, it looks like the investigators are all at McGill University in Montreal. No one in the U.S. is listed.

Here's the company's announcement on the FDA fast-track approval. This dates from mid-2022:
https://www.salspera.com/blog/fda-grants-fast-track-designation-to-salspera-s-saltikva-an-innovative

To clear up the misconception regarding Saltikva, it did not receive “fast track approval” by the FDA. It received “fast track designation” meaning faster and more frequent interaction with the FDA is reviewing the data from clinical trials. At the moment, Saltikva is in a very small clinical trial of 28 patients out of McGill University in Canada. Review of the data from the phase II study must be done before the FDA approves it for a larger phase III study which is more representative of the general population as it includes patients that are more ill than the ones accepted into the phase II cohort.

Fast track approval expedites the review process when an investigational new drug (IND) meets the end point objectives showing superiority over a current treatment or there is an unmet need for treating a condition. It will take some time fore the phase III trial is launched, accrual of patients and preliminary data. Until then the IND would not be available to patients outside of the trial.

Update: I actually wrote to Salpsera (the company based in MN who manufactures Saltikva). They emailed me personally to speak to my sister's oncologist and to contact them. The drug would be available free of charge if all criteria could be met. Compassionate Care Use document was provided to me. Fast track designation and fast track approval was indeed misunderstood, but if more people with this dreaded disease request to participate, perhaps we can make a difference in the availability of this drug.
I only hope the "Compassionate Care" will be extended not only to my sister but to all who can benefit. Nothing would make this year better than to have my sister here as long as possible.

For which gene mutation is this drug targeting?

You can email them at: info@salspera.com

This link and some of the others on that page might be useful to someone at some point.
https://www.fda.gov/news-events/public-health-focus/expanded-access

https://www.salspera.com/blog/salspera-announces-increase-in-survival-of-stage-4-pancreatic-cancer-patients

agreed totally,my sister has it,and this drug would be a great break through for anybody the has pan-cam! and to think it doubles their time just amazes me, maybe we are finally getting closer to a cure! god blessand thank you for sharing this with us

Do you know if it must be used w Folfirinox?
What if you tried Fol and it didn’t work so you switched to Gem?