Keytruda FDA Breakthrough Therapy Designation for MSI-High CRC

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DK37
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Joined: Tue Sep 17, 2013 8:31 am
Location: San Diego

Keytruda FDA Breakthrough Therapy Designation for MSI-High CRC

Postby DK37 » Tue Nov 03, 2015 10:53 am

As expected... with this high of response rate of PD-(L)1 inhibitors in MSI-CRC, Merck's version got a Breakthrough Therapy Designation from the FDA~ http://www.businesswire.com/news/home/2 ... -U.S.-Food

-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
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daisydaisy
Posts: 71
Joined: Wed Dec 11, 2013 12:19 pm

Re: Keytruda FDA Breakthrough Therapy Designation for MSI-High CRC

Postby daisydaisy » Tue Nov 03, 2015 4:21 pm

You posted about it in May - wow! By the way, I made a search here about keytruda, and one member, MikeW mentioned that he worked for Merck.
It is amazing to observe how promising drugs are being developed. And thank you, as usual, for providing us with this info!

ieowi
Posts: 202
Joined: Mon Jul 27, 2015 1:27 am

Re: Keytruda FDA Breakthrough Therapy Designation for MSI-High CRC

Postby ieowi » Tue Nov 03, 2015 6:39 pm

Thank youUUUUUuUUUUUUuUUUUuuuuuuUuuuu DK37
Now let's hope something work out for MSS MSI-LOW
Father 58 yo , Colon cancer IV + 4 Lymph. 7/2015
K-ras Mutant,GNAS,FBXW7,PIK3CA, MSI-low
4 cycles irinotecan+FU5
developed abdominal met + lung met...Failed
4 cycle Oxaliplatin+folfox. peri met growing...Failed
unofficial trial !!!

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DK37
Posts: 510
Joined: Tue Sep 17, 2013 8:31 am
Location: San Diego

Re: Keytruda FDA Breakthrough Therapy Designation for MSI-High CRC

Postby DK37 » Wed Nov 04, 2015 12:48 am

daisydaisy wrote:You posted about it in May - wow! By the way, I made a search here about keytruda, and one member, MikeW mentioned that he worked for Merck.
It is amazing to observe how promising drugs are being developed. And thank you, as usual, for providing us with this info!


When another PD-1 inhibitor submitted for FDA approval (for lung cancer) - the FDA approved it in 4 DAYS. If the preliminary data in MSI-high CRC repeats in the larger trial in progress (which at least roughly I think it probably will) - I expect a very fast approval decision for MSI-high CRC. Immunotherapies have changed everything in oncology drug development... Now hopefully MSS-CRC's turn some time soon!

-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List

Nik Colon

Re: Keytruda FDA Breakthrough Therapy Designation for MSI-High CRC

Postby Nik Colon » Wed Nov 04, 2015 12:51 am

DK37 wrote:Now hopefully MSS-CRC's turn some time soon!

-DK

Yes, I hope so too!


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