FDA Approved Oral SERD - Elacestrant (ORSERDU) 1/27/23!!!

[hopenowandtomorrow]

Hi fellow MBC’ers: Here’s the latest approval from the FDA on approval of the Oral SERD that takes the place of the monthly (painful) Faslodex injections:

The drug is called “ORSERDU”

fda.gov/drugs/resources-inf...

accessdata.fda.gov/drugsatf...

The FDA also approved a Guardant 360 test for ESR1 mutuations.

Hopefully, those of us with ER+ breast cancer will have less pain going forward!

❤️🙏❤️

[Wintervt]

I'm starting it today.

[hopenowandtomorrow in reply to Wintervt]

Hi Wintervt: Are you really starting it today? If so, how did you get your Oncologist to change the treatment from Faslodex? How much does ORSERDU cost?

Thank you!

❤️🙏❤️

[Wintervt in reply to hopenowandtomorrow]

Hi,

I literally took my first pill fifteen minutes ago. In terms of cost, I'm not sure as it is covered by my insurance with a co-pay of $4.00. I’ve been taking Tamoxifen and Verzenio for 18 months and it stopped working. I have the ESR1 mutation and my oncologists in Vermont and Boston felt this would be a good choice for me.

Best,

Jade

[Red1246 in reply to Wintervt]

So hope it works for you! 🙏🏻

[Wintervt in reply to Red1246]

I hope it does! I planned to participate in the trial for this drug three years ago but didn't qualify as I was not post-menopausal.

[DDIL1 in reply to Wintervt]

Hi! Did you switch because Fulvestrant stopped working? As you know I’m like you ESR1. But I just started Fulvestrant. Thinking I’ll switch if this fails. I hope it works great! Keep us posted.

[Wintervt in reply to DDIL1]

Hi DDIL1,

Fulvestrant was my second line of medication, and it did not work for me.

Best,

Jade

[mariootsi in reply to Wintervt]

Jade, I wish you the best with the new serd. Let us know if there are any side effects.

[Wintervt in reply to mariootsi]

Thank you! I will keep you all updated! 💕

[mariootsi in reply to Wintervt]

Thanks Jade.

[Wintervt in reply to mariootsi]

How are you feeling these days? Are you still on your first line of meds?

[mariootsi in reply to Wintervt]

Thank you so much for asking! I am still on Ibrance and Faslodex shots, but with the addition of Xgeva soon. My bone scan showed some spots but ct scan showed shrinkage. Will know more after next scan at the end of April.

Have to see my dentist before starting Xgeva. Take care Jade.

[HbbM in reply to Wintervt]

I may be starting this soon. How are you doing?

[hopenowandtomorrow in reply to HbbM]

I am not on the new oral drug (ORSERDU) because my genome test did not come back with any indication of the ESR1 marker. Sadly, I’m stuck (no pun intended) with the Faslodex shots for now.

I’m hoping the FDA will approve the drug without the ESRI marker required.

I’ve had 4+ years of Faslodex shots & the scar tissue in my gluts is creating other problems for me.

I’d like to hear from those on the oral drug, how they are doing???

All the best!

🙏❤️🙏

[HbbM in reply to hopenowandtomorrow]

I’m sorry, I thought I was responding to wintervt and asking her. But I would like to ask you… is faslodex the injection version of this new drug or is it something different?

[hopenowandtomorrow in reply to HbbM]

Hi HbbM: Yes, Faslodex is administered via the 2 monthly shots that do the same thing as this newly FDA approved oral estrogen inhibitor. The pills are supposed to be more effective and certainly less painful. I hope that helps!

🙏❤️🙏

[Wintervt in reply to HbbM]

Hi Hbbm,

I'm doing well on the drug; my tumor markers are trending down. I'm due for scans next month.

Jade

[HbbM in reply to Wintervt]

side effects are ok? I’m a bit concerned about the side effect of lower hemoglobin.

[Godbeforme]

Thanks for posting and keeping us all informed! God bless you and heal us all in Jesus name, amen! <3

[Threadsgirl]

Thank you for posting this, I looked at the link and the drug seems to have good results. Doesn’t seem to have too many bad side effects either….

[valentinecalico]

Thank you for the links! Hoping this is approved in Canada soon too. Would love to hear updates from people who are now starting this medication. The fact that it's oral and not injections is not only more convenient, it's my understanding that they are able to give a higher dose orally than is possible via the muscles (eg fulvestrant). Good news all around hopefully.

[hopenowandtomorrow]

Hi Valentine Calico! Your name reminded me of this cat! Happy Valentine’s Day early 😻

Happy Valentines Day!!!

[Lilsusie]

Thank you for this wonderful information.

[Iwasborntodothis]

We are discussing this at my appointment today because Taxol has stopped working. I am surprised that he would put me back on pills (especially since it is related to Falsodex and that didn't work for me at all) and that no chemo is an option. Guess we will see and see if insurance approves.