Another arrow in the quiver. (And on... - SHARE Metastatic ...
Another arrow in the quiver. (And one less shot in our butts) FDA approves first oral SERD
does this mean it will only work with ESR1 mutations, or no?
between the lines I think it is only approved for those w that mutation because that’s the context in which it works better. I wonder though if there will be wiggle room if one’s doctor pushes.
I am having a biopsy soon and am hoping I’m a mutant!
Thanks for posting!!! I have the ESR1 mutation and this is good news. Till now, they had nothing for us. ESR1 is a rough mutation. What it does is make you endocrine resistant - meaning all the AIs and CDK4/6 inhibitors no longer work. In essence, it’s sort of like being triple negative, even though you have HR receptor positive cancer.
Many women have this mutation and, speaking without clinical data to back me up—just my own understanding—this mutation is responsible for probably 35% of metastatic deaths. Hopefully, this spurs more research $ and more effective drugs!
An oncologist I saw for a second opinion at Dana Farber told me ESR1 is the hottest research topic in the metastatic BC oncological community.
😻
interesting. I did not know that was what that mutation does. I look forward to discussing with my doctor
I have read posts on various boards by women who were on the trials. It doesn’t seem to be the longest lasting treatment—about a year it seems, but the side offers seem not too bad. Hopefully you can try it!
The research money for ESR-1 is being done under breast cancer. What I hope is that those of us with metastatic endometrial cancer (er+ pr+ and HER2-) get the benefit of this research at the same time. I’m lucky because my drs are more openminded. I really appreciate the information that is shared by you lovely people, because that’s the only way I can stay on top of my cancer and my oncology team. ❤️🧜♀️
I too was just diagnosed with the ERS1 after one year since initial diagnosis. Oral SERMS will be coming too I heard. Additionally, if there are other mutations you have that could add additional therapy. They found somatic BRCA2 so that gave me 4 more lines. Mutations I think can be helpful at times. But I’d rather not have them. How long have you had ESR1 and how are you doing? I was switched from Ibrance/ Letrozole to Kisquali/faslodex. I’m lobular too.
As a quick clarification: ESR1 mutation is indicative that AIs and Tamoxifen may not work, but it is not indicative of resistance to CDK4/6 inhibitors per se, nor of resistance to SERDS.
yes, i take verzenio/Folsadex seems working well
yay! hooray! thanks for posting <3
Just talked to my doctor last week about it. She said I was a candidate once it was approved, because I did so well in a clinical trial of another oral SERD. I do not have the ESR1 mutation, though, so it sounds as though insurance won't cover it. The benefit is primarily for those with that mutation -- and that is great, because yes, that mutation makes the AIs ineffective. There is still a benefit for some without the mutation, and it is effective longer for those who had at least a year on CDK4/6 inhibitors. When I was on the oral SERD, that is the only medication I took, and I was NEAD for a year.
I hope it is covered for non ESR1 mutations, but probably not. Let us know if there is more news!
This is great news. I’ve been watching the trials and data and San Antonio discussions on this oral SERD and was expecting to see the FDA approval next month. Ironically it was approved on the same day we felt we had to start my wife on IV Chemo (Gemzar) as there were no other oral options. I saw the approval when we got home from the infusion. Sometimes things happen for a reason and we’re just hoping the Gemzar is the right option for her right now, but it’s great to know that there’s an oral option available for the next step. She does have a slight mESR1 mutation from a Guardant360 test so it looks like she would qualify for it. L
The nature of the approval and the language in the press coverage is surprising to me. Based on my (certainly imperfect) read of the trial data I felt there was clear benefit shown for patients with non-ESR1 mutations, the median PFS was just a bit shorter. Also, the median PFS for some groups (on CDK 4/6 for over 12 months) was 8.4 months. It’s strange that none of the press releases or FDA advisories are highlighting the higher benefit for certain groups and they’re simply stating the lowest median PFS numbers from the studies.
Regardless, this is great news. I would expect and hope it will also be approved for non-ESR mutation patients in the near future and that this particular approval only for ESR1 mutations was expedited since the data was simply more compelling and easier to justify the benefit to get it out to market. Hope there’s more to come.
What is the guardant 360 test? How is it done?
Guardant 360 is a liquid (blood) genomic “biopsy” test. Although most oncologists prefer tissue biopsies, I’m glad to see that the FDA is not requiring that to asses ESR-1 mutations. A blood test is much easier and safer to do than trying to get a tissue biopsy.
Thank you so much for sharing! I have been waiting for this news - though l am not sure l can tolerate more musculoskeletal pain than l have now.
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