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Trodelvy approved by FDA

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Forum Name: TNBC Metastasis/Recurrence Users
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URL: http://forum.tnbcfoundation.org/forum_posts.asp?TID=13811
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Topic: Trodelvy approved by FDA
Posted By: SagePatientAdvocates
Subject: Trodelvy approved by FDA
Date Posted: Apr 07 2021 at 6:44pm
https://www.onclive.com/view/fda-grants-regular-approval-to-sacituzumab-govitecan-for-tnbc?utm_source=sfmc&utm_medium=email&utm_campaign=4-7_OncLive_Breaking_Unsponsored%20v2&eKey=c3RldmVAc2FnZXBhdGllbnRhZHZvY2F0ZXMub3Jn" rel="nofollow - https://www.onclive.com/view/fda-grants-regular-approval-to-sacituzumab-govitecan-for-tnbc?utm_source=sfmc&utm_medium=email&utm_campaign=4-7_OncLive_Breaking_Unsponsored%20v2&eKey=c3RldmVAc2FnZXBhdGllbnRhZHZvY2F0ZX
Mub3Jn

Sacituzumab a/k/a Trodelvy was approved by the FDA today.

with my love to all here,

Steve


-------------
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates



Replies:
Posted By: carmenlynn3
Date Posted: Apr 15 2021 at 4:23pm
HI, MY mom diagnosed with metestatic triple negative.  Receiving first treament today at Mayo Phoenix, We would appreciate any input.  
Treatment plan, April 2021
 there will be 6, 28 day cycles with weekly chemo.  Each visit includes Tezolizumab, and day 8 will also add Abrazane/paciltaxol

74 y.o. female with a history of clinical stage I (cT1ccN0cM0, ER-, PR-, HER2-, grade 3) upper inner left breast cancer, now with metastases to lung and liver.

HISTORY OF PRESENT ILLNESS

She was on clinical trial: RU011501 folate receptor alpha vaccine. She has started to developed some dyspnea on exertion and shortness of breath, in particular in her right lower lobe. Evaluation led to imaging, and identification of a large left lower lobe necrotic lung mass, with regional adenopathy. He was not clear if this was a primary lung cancer or a metastatic lesion. She does have a long history of tobacco use. She was also found to have multiple liver lesions. She underwent biopsy of both, final pathology was consistent with metastatic triple negative breast cancer. PDL1 testing of the liver lesion showed 1% reactivity by immunohistochemistry.

ONCOLOGIC HISTORY
Oncology History Overview Note
She reports in 1997 she developed left breast DCIS which was identified on screening mammography. We do not have the record of receptor status. She received lumpectomy followed by radiation.

The patient otherwise was healthy until 2005 when once again on screening mammography she was found to have a right breast mass. This was biopsy proven to be invasive ductal carcinoma ER negative, PR negative, HER2 negative. The tumor measured 1.3 cm and was grade 2. She was given the clinical stage I. For therapy she received lumpectomy with intraoperative radiation followed by postoperative radiation. She also received Adriamycin, cyclophosphamide and paclitaxel. She had to discontinue paclitaxel early prior to completing therapy secondary to peripheral neuropathy development.

In April of 2019 the patient had missed her screening mammography in 2018. She presented for screening mammography where the noticed an abnormality in her left breast. This is followed by ultrasound which confirmed an approximate 1 cm mass at the 11 o'clock position in her left breast. The patient subsequently received MRI which showed this 7 mm mass in the 11 o'clock position as well as a 4 mm mass in the left breast. The over-read of this MRI at Mayo Clinic confirmed the 7 mm mass in the 11 o'clock position but son no other abnormalities. On 05/06/2019 she underwent ultrasound-guided biopsy which showed invasive ductal carcinoma, grade 3, ER negative, PR negative, HER2 negative. None of the imaging studies showed concern of lymph node involvement. She was given the clinical stage, stage I.

She received neoadjuvant carboplatin and gemcitabine chemotherapy with partial disease response, she did not tolerate paclitaxel. She has had bilateral pulmonary emboli on Xarelto. Genetic testing showed:
Positive Results: Pathogenic PALB2 c.1248del (p.Met416Ilefs*8) variant
Uncertain Results: VUS in POLE c.461G>A (p.Arg154Lys)

She underwent bilateral mastectomy under the care of Dr. Barbara Pockaj on November 15th. She had a residual 12 mm tumor, ypT1c N0, RC B2, 20% cellularity.

Thank you Carmen 602-434-1289    carmengustin@gmail.com



Posted By: JoanE
Date Posted: May 31 2021 at 7:52pm
Hi all,

I'm about to start treatment with Trodelvy, having gone thru AC (no benefit), Tecentriq and Abraxane (full remission for several months)tecentriq on its own and breast radiation (metastisized to brain and liver. nothing in breast) Has anyone else had any experience with this drug? If so, how was it and do you have any results?

Thanks.

Joan


Posted By: SagePatientAdvocates
Date Posted: May 31 2021 at 9:14pm
Dear Joan,

I am helping several women who are taking Trodelvy. Anecdotally, I can tell you that it seems to be helping some of them. I hope you will hear from some of the women regarding their experiences. 

Sorry, I cannot provide any names because I keep all information on anyone I am helping confidential. But, I am hopeful you will hear from someone. It is still pretty early days since approval for Metastatic TNBC. 

good luck to you!!!! 

warmly,

Steve




-------------
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates


Posted By: Plume
Date Posted: Oct 05 2021 at 3:51pm
Steve, I have just read your post, having searched for Todelvy and feel uplifted and excited.  The French government has approved this for use from 1 November!

Although I haven't needed this drug, I'm so happy that at last tnbc patients have SOMETHING that is for them.

I remember how bleak it felt after my last radiotherapy session when the consultant said that my treatment was completed and that there would be nothing further planned.

It might sound crazy not to be relieved that there would be no more sessions of anything but, hard as the surgery, chemo and radio were, they had become a safety blanket for me and I was angry and confused to be told that there would be nothing else apart from check-ups.



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