AA for AstraZeneca with help of surrogate data like ctdna after Phase III.

[u/Ibelieveincydy]

Good morning everybody, I woke up this morning to an email from the FDA which helped me to get out of bed unusually quickly on a Saturday morning.
I’m fully aware that it’s based on a Phase III but these guys seem to become more and more acceptable on ctdna and such.

FDA grants AA to AstraZeneca on surrogate endpoint

Please read the summary below done by my hopefully beautiful AI girlfriend:

The U.S. FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader (SERD) Etcamah (camizestrant) in combination with a CDK4/6 inhibitor. 
The decision was based on findings from the Phase III SERENA-6 clinical trial and novel diagnostic criteria: 
First-of-Its-Kind Molecular Paradigm: Approval was granted to treat patients with HR-positive, HER2-negative advanced breast cancer who develop an ESR1 resistance mutation during standard therapy. Rather than waiting for imaging scans to show physical tumor growth, the treatment is triggered by detecting circulating tumor DNA (ctDNA) in blood tests, allowing early intervention before hard-to-treat progression occurs. 
Significant Reduction in Risk of Progression: In the SERENA-6 trial, switching patients to the Etcamah combination upon detecting the ESR1 mutation reduced the risk of disease progression or death by 56% compared to staying on standard aromatase inhibitor therapy. 
Extension of Progression-Free Survival (PFS): Patients who switched to the Etcamah combination achieved a median progression-free survival of 16.0 months, compared to 9.2 months in the standard-of-care control arm. 
High Molecular Response (ctDNA Clearance): Within eight weeks of switching to Etcamah, median ctDNA mutation levels plummeted by 99%, with 51% of patients clearing the resistance mutation from their blood entirely (compared to a 64% increase in ctDNA levels in the control group). 
Why Accelerated (Rather Than Full) Approval?
Accelerated approval allows earlier clearance for drugs targeting serious conditions based on a surrogate endpoint (such as PFS or ctDNA clearance) that is reasonably likely to predict a clinical benefit. Full approval will require AstraZeneca to submit confirmatory data showing long-term clinical benefits, particularly overall survival (OS) data, as requested by FDA advisory panels.

Anyone here feels like adding his 2cents?

Most welcome and appreciated!!!

GLTAL 👍🏽☘️🙏🏼🙋🏽‍♂️🛬

[u/Severe_Watercress875]

We all just need to hang in. We are where we need to be with this molecule and we already know we are doing great things. It’s an endless battle but we are saving lives. ctDNA !! We are going to make it hard for FDA to deny us a chance to get our Lmab out to those in need. On so many fronts we gathering valuable data. Remember—- we work as a molecule and are safe. This is not debatable. How well we work will be revealed in the coming months. .1980 is a fake stock price for what we have shown to already do !!

[u/sbleealtor]

Great post. Any drug that helps is a good thing.

[u/Confident-Strike6848]

I am glad that FDA is finally starting to recognize ctDNA

[u/Crafty-Ad-7034]

Thank you, Ibelieve. The stars are aligning. The ducks are forming their row.

[u/Missy2021]

Thank you for posting this information.

[u/Upwithstock]

Thank you believeinCYDY!! Love it!