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FDA Warning Atezolizumab/Paclitaxel

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    Posted: Sep 08 2020 at 3:36pm
FDA issues alert regarding efficacy and safety of Atezolizumab/Paclitaxel in Breast Cancer

https://www.onclive.com/view/fda-issues-alert-regarding-efficacy-and-safety-of-atezolizumab-paclitaxel-in-breast-cancer?eKey=c3RldmVAc2FnZXBhdGllbnRhZHZvY2F0ZXMub3Jn

"The FDA has issued an alert that the phase3 IMpassion131 trial failed to show the effectiveness of atezolizumab plus paclitaxel in treatment-naïve patients in inoperable 
locally advanced or metastatic triple negative breast cancer."

I attended a breast cancer seminar last fall and one of the experts was asked about immunotherapy for breast cancer and he expressed doubts about using immunotherapy drugs for breast cancer as compared to other cancers. Having said that, I am not saying folks should make immunotherapy part of their treatment plan or not. 

Also, the FDA warns "that practitioners should not substitute paclitaxel protein-bound with paclitaxel in clinical practice" so for those of you starting paclitaxel please check with your Breast Medical Oncologist that you are receiving 'regular' paclitaxel.

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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Sep 09 2020 at 12:01pm
Thanks for posting this Steve.  It looks like the warning at this time is for Taxol, but not Abraxane.  We'll have to see if they change the authorization in the future for Abraxane. 

FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel (Taxol) in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.  

Atezolizumab in combination with paclitaxel (Taxol) is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound (Abraxane)—a different combination therapy—is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Continued approval of atezolizumab in combination with paclitaxel protein-bound may be contingent on proven benefit of the treatment in additional trials.

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Sep 14 2020 at 8:39pm
I believe there is a little more detail in this release..some duplication from original post and Donna's but some more context, I feel.

with my love to all here,

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
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