While this (MSI-H) is not one of the highest burden cancers in the US, it is worth noting that this indication had been granted both (i) a priority review, and (ii) breakthrough status by FDA, in late 2015.
Now the FDA staffers are asking for more data. The would-be FDA complete response date should have been March 8, 2017. That date miss would more than occasionally suggest some smallish off-target effect was emerging, in the data -- or there were questions about the efficacy, in this patient population. I suspect that it will all sort itself out, but this has to be disappointing news, to Kenilworth. From OncLive, then:
. . . .The sBLA for pembrolizumab is based on results from 5 open-label, multicohort phase I/II trials that evaluated pembrolizumab in patients with MSI-H tumors. The specific regimen would be a fixed dosed of 200 mg of pembrolizumab every 3 weeks.
In November 2015, the FDA granted a breakthrough therapy designation to pembrolizumab as a potential therapy for patients with MSI-H metastatic colorectal cancer (mCRC). . . .
As ever, very rare is the biologic that progresses in a straight line -- this we all know, from painful experience. Onward.
नमस्ते
5 comments:
ok~~off topic but I believe relevant (and mind you I do understand artistic license) however, using either the desert scene or an iceberg to argue against 'life...' just ain't so:
http://scienceblogs.com/notrocketscience/2009/05/17/icebergs-are-hotspots-for-life/
and
https://www.q-files.com/life/ecosystems/desert-life/
I know, not the 'best sources' but, you get my feelings.......
Oh my.
Truly, Anon. -- I hear you. And what I'm driving at (badly it seems). . . Is the desolation -- the loneliness, and the futility, ultimately -- of conducting life science RESEARCH without the best team on the field.
I meant for the pictures to be devoid of. . . humans.
You are quite right (as we are very likely to learn -- even on Europa!) that life itself is abundant almost everywhere water flows.
I intended to make the point that restrictive immigration policy harms good science research.
Do stop back! I really do appreciate the dialogue!
Namaste
Later I'll revise the copy to say "life science research programs". . .
Fair enough?
Smile. . .
we can accept that~~~
Imagine my. . . relief!
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