Friday, May 26, 2017

CANCER BREAKTHROUGH DRUG - and a clear look at exceptions

"In Bold Move, FDA Approves Cancer Drug For Any Advanced Tumor With Genetic Changes"  Forbes  Elaine Schattner 


I almost gave up on this article (which was on Twitter this week) because I'm not familiar with the disease types that may be helped.  

But the writing is so clear and important that I marched through the first two paragraphs.  And found the WHY of this important turning point:

"It suggests the agency may be ditching an archaic system for classifying cancers based on body partslike breast or liver or colon cancer—and instead will focus on molecular aspects of malignancies, qualities that render tumors 
vulnerable, or not, to targeted drugs."


We're talking about Keytruda.  And we've arrived at the possible problems and considerations;:


"The FDA cites data compiled from five non-randomized studies that support this drug’s effectiveness in various tumor types."  Generally, I hesitate when I see the words non-randomized studies.

Then: $Cost.  Big.  And high toxicity. 


Then two things I would hope for if it were my tumor, my body: physician's judgment.

And appropriateness/accuracy: 
"Distinct ways of checking tumors for these abnormalities could yield variable results."

Yes, a tough road, tough decisions.  

And I remember something beautiful I retweeted this week: with apologies to the original writer, 
something about the patient being the only one who knows all that's really going on in his body.


I wish you health.




 

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