Jul 23, 2026 · 18 min · 7 segments
This week's pod covers some brief updates comparing the timelines of the FDA approvals for daraxonrasib vs. enfortuamb vedodin + pembrolizumab, before devoting the rest of the time to the new approval…
John BazarHost
Direx Onrecip, the OnRAS inhibitor with really promising overall survival benefits, second-line metastatic pancreatic cancer, has been accepted now.
which means now FDA is able to review the materials and hopefully grant approval for the product as soon as possible.
Just, you know, on a prior podcast, I talked about how it was kind of odd for FDA to come out with this compassionate use program so early.
And I hypothesize maybe this is because it's a new drug company and they're learning how to submit to FDA.
So on April 13th, now more than three months ago, the company put out their press release saying we have, quote, unprecedented survival in pancreatic cancer, which ended up being true.
About two weeks later on 4-28, They request FDA to allow compassionate use of their product.
Okay, so the company does their press release two weeks after that, compassionate use is requested and kind of granted.
And then a month after that, we get the publication, which I'm pretty sure was simultaneous with ASCO, which would have been around that time, end of May, 1st of June.
So this... company was, um, is a new company is putting together all their data, generating interest, but now press release.
My guess is this company maybe gets sold or somebody buys rights to this with a higher stock price, but it's taking a little bit longer to get the FDA approval, which should get access to patients faster.
There's another unanswered question, which is gonna be commercial availability of this drug and the manufacturing capability to ramp up to make as much drug as the demand I think is gonna be for this.
Direx Onrecip, the OnRAS inhibitor with really promising overall survival benefits, second-line metastatic pancreatic cancer, has been accepted now.
which means now FDA is able to review the materials and hopefully grant approval for the product as soon as possible.
Just, you know, on a prior podcast, I talked about how it was kind of odd for FDA to come out with this compassionate use program so early.
And I hypothesize maybe this is because it's a new drug company and they're learning how to submit to FDA.
So on April 13th, now more than three months ago, the company put out their press release saying we have, quote, unprecedented survival in pancreatic cancer, which ended up being true.
About two weeks later on 4-28, They request FDA to allow compassionate use of their product.
Okay, so the company does their press release two weeks after that, compassionate use is requested and kind of granted.
And then a month after that, we get the publication, which I'm pretty sure was simultaneous with ASCO, which would have been around that time, end of May, 1st of June.
So this... company was, um, is a new company is putting together all their data, generating interest, but now press release.
My guess is this company maybe gets sold or somebody buys rights to this with a higher stock price, but it's taking a little bit longer to get the FDA approval, which should get access to patients faster.
There's another unanswered question, which is gonna be commercial availability of this drug and the manufacturing capability to ramp up to make as much drug as the demand I think is gonna be for this.
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