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FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Mon Jun 29, 2020 9:20 am
by Jack&KatiesMommy
The FDA has approved the immunotherapy Keytruda for solid tumors with a tumor mutation burden of 10 or greater. This means that CRC patients with MSS tumors (with TMB of 10+) are able to get insurance coverage for the use of Keytruda! My oncologist had to petition and appeal to get my insurance to cover Keytruda for me. I have been in it for over 2 years and am a “complete responder.” I am MSS (and all my chemo options were no longer working. I had cancer in lymph nodes near my lungs when I started Keytruda in May 2018). My doctor ordered Foundation One testing and found that I had a TMB of 11....and thought that Keytruda was a final option to try. Today I am cancer free (9 years after initial diagnosis of stage IV colon cancer and lots and lots of chemo and surgeries and rfa’s.

https://www.fda.gov/drugs/drug-approval ... lid-tumors

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Mon Jun 29, 2020 11:57 am
by Rikimaroo
This is great news. My Onc mentioned something about FDA approved something, not sure if it was Keytruda, but will talk to him. My TMB is 8, but I want him to do a new test from my last surgery, will talk to him about it.

So when you say your Cancer free, are you not doing any regimen at the moment? I hope this is the case and truly happy for you!!

Riki

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Mon Jun 29, 2020 12:12 pm
by Claudine
Fantastic! We do not know DH's TMB but it's one more weapon in our arsenal for potential future fights. Thanks for sharing!

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Mon Jun 29, 2020 6:28 pm
by Vana3
That’s awesome!
Thank you so much for sharing this news!

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Mon Jun 29, 2020 10:29 pm
by Jack&KatiesMommy
Rikimaroo wrote:This is great news. My Onc mentioned something about FDA approved something, not sure if it was Keytruda, but will talk to him. My TMB is 8, but I want him to do a new test from my last surgery, will talk to him about it.

So when you say your Cancer free, are you not doing any regimen at the moment? I hope this is the case and truly happy for you!!

Riki


Hi Riki:
I would definitely get your TMB checked again. My oncologist thinks that mne was so high due to to the prior 7 years of treatment I had gone through (multile years of chemo, rfa's etc.)

An I am currently still getting immunotherapy...but there is no evidence of disease. The immuntherapy worked...but there is no guidance as to when it is safe to stop and I am not ready to be the person to "give it a shot." It is an infusion every 3 weeks with very few side effects (fatigue ony for me).

Cynthia

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Mon Jun 29, 2020 11:45 pm
by beach sunrise
This is absolutely news to shout about!!!

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Tue Jun 30, 2020 5:15 pm
by Rikimaroo
Cynthia,

That is awesome news. Very happy things are working and your here for a long time to enjoy your beautiful family. So the side effects Fatigue is nothing like being on FolFIRI? not even close right? How long does the fatigue last for? That CEA at .8 is the most wonderful number. I was there from my first surgery after I was 600+ CEA, love the .8 CEA.

Riki

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Thu Jul 02, 2020 1:30 am
by WarriorSpouse
Great news Cynthia! Thank You for sharing this with us. I am glad it is working well for you.
All the best!
WS

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Wed Jul 08, 2020 9:34 pm
by boswind
Excellent!!! Unfortunately, I failed pembrolizumab last year although my TMB was 12.

Re: FDA Approved Keytruda for MSS Tumors w/ TMB of 10+!!!

Posted: Thu Jul 09, 2020 4:05 am
by Siti
Thank you for sharing and very happy you’re NED. Your fighting spirit is an inspiration!