Pashtoon Kasi, Medical Director of GI Medical Oncology at City of Hope Orange County, shared Nicholas Hornstein’s, Assistant Professor at Northwell Health, post on X, adding:
“‘FDA clock officially started.’
Loosing count on the number of requests and patients with pancreas cancer now on expanded access.
Getting close to the finishing line.”
Quoting Nicholas Hornstein’s post:
“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.”
Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S.
FDA for Previously Treated Metastatic Pancreatic Cancer
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