Nicholas Hornstein, Assistant Professor at Northwell Health, shared on X:
“This is the daraxonrasib news I’ve been refreshing the RevMed site for!
The NDA has been accepted for FDA review.
And before anyone says it: no, this is not ‘late.’
NDA packets are enormous. Clinical data, CMC, safety, labeling, subgroup analyses, QA, regulatory back-and-forth. It takes time to package a drug for FDA review, especially when the goal is not ‘nice phase 1 signal’ but actual approval.
Now the timer starts.
Why does this matter?
An oral RAS inhibitor with phase 3 PFS and OS benefit is a big deal. I think we’ve all said that enough by now.
Now the FDA gets to do what it has said it wants to do:
Get life-saving drugs into patients’ hands as quickly as possible (outside of an EAP program).
FDA clock officially started.”