Posted On: 11/14/2015 11:03:42 AM
Post# of 72441
10m Intvw w/ Dr Richard Pazdur -- FDA Dir of Hema/Onc -- and his wife Mary, who was diagnosed 3 yrs ago w/ovarian cancer.
http://www.cancerletter.com/articles/20151023_6
Of note, his comment, about halfway in, re the "Underestimation of drug toxicities" - the impact of side effects, quality of life considerations. "Fatigue is not just a Grade 2 toxicity, it's a life altering one." Why Kevetrin being safe and well-tolerated is prob equally impt as its efficacy in the current radiation/chemo-heavy, hard-on-the-body, treatment of advanced cancers.
Pazdur goes on to say listening to patients (more a "cry" than "voice"
matters--not getting so hung up on PFS and OS (statistics)--and broadening eligibility criteria in clinical trials... Trials that are more "humanistic." FDA as drug development partner.
Gotta think Kevetrin, esp for Ovarian, on his radar for obvious reasons.
Another couple vids -- him accepting cancer advocacy award, twd the end he comments some more on impt of Patient Voice; the second vid is a short clip on Breakthrough Designation (not submitting an application prematurely ... Ie, where Kevetrin is...... ) Should the Ph I writeup make it into print, it'll be a good first look determining just how revolutionary Kevetrin might be on the p53 front.
http://youtu.be/gocMqL9T20M
http://youtu.be/t5CG3TUX5e4
http://www.cancerletter.com/articles/20151023_6
Of note, his comment, about halfway in, re the "Underestimation of drug toxicities" - the impact of side effects, quality of life considerations. "Fatigue is not just a Grade 2 toxicity, it's a life altering one." Why Kevetrin being safe and well-tolerated is prob equally impt as its efficacy in the current radiation/chemo-heavy, hard-on-the-body, treatment of advanced cancers.
Pazdur goes on to say listening to patients (more a "cry" than "voice"
matters--not getting so hung up on PFS and OS (statistics)--and broadening eligibility criteria in clinical trials... Trials that are more "humanistic." FDA as drug development partner. Gotta think Kevetrin, esp for Ovarian, on his radar for obvious reasons.
Another couple vids -- him accepting cancer advocacy award, twd the end he comments some more on impt of Patient Voice; the second vid is a short clip on Breakthrough Designation (not submitting an application prematurely ... Ie, where Kevetrin is...... ) Should the Ph I writeup make it into print, it'll be a good first look determining just how revolutionary Kevetrin might be on the p53 front.
http://youtu.be/gocMqL9T20M
http://youtu.be/t5CG3TUX5e4
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