and good to see you over here too... posted this
Post# of 72445
Posted On: 08/25/2015 2:49:52 PM
Re: someconcerns #13153
and good to see you over here too...
posted this to the other Board
//
Approval After Phase I: Ceritinib Runs the Three-Minute Mile
Oncologist. 2014 Jun; 19(6): 577–578.
Published online 2014 May 1. doi: 10.1634/theoncologist.2014-0143
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4041677/
EXCERPT
Thirteen years ago, I wrote an editorial applauding discovery, development, and marketing approval of imatinib for chronic myelogenous leukemia (CML), a signal event in the history of targeted therapy, and the oncology equivalent of the four-minute mile [1]. It took 3 years from the start of trials and required the confirmatory evidence of two phase II studies to receive the U.S. Food and Drug Administration’s (FDA) stamp of conditional approval. A decade later, these pages called attention to the rapid 3-year development of crizotinib for ALK-translocated non-small cell lung cancer (NSCLC), again based on a highly positive phase I and a confirmatory phase II [2]. In that editorial, I predicted that, someday soon, the FDA would approve a new targeted agent after phase I. That day has come to pass with the approval of ceritinib for ALK-rearranged NSCLC.
The strategy for targeted drug development is now radically different from the equivalent trials of cytotoxic drugs. In the case of ceritinib, the research team knew the drug’s target, were able to select the patients that have tumors expressing the target, and could quickly expand the phase I study to include large numbers of patients, thereby accumulating convincing data on efficacy and safety in phase I. The old saw that phase I is all about safety and phase II is all about efficacy no longer applies. Phase I is all about Proof of Principle and efficacy, once a safe dose is reached. [sounds familiar]
Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper
http://www.forbes.com/sites/aroy/2012/05/04/s...ew-herper/
https://youtu.be/V8x446Yd7_Y
to my mind, the above means Kevetrin is setting up well... how "convincing" the data coming out of K's Ph I in adv of the planned Ph IIs---now that is the Q... hints, but more proof obv needed. if it adds months in PFS, Breakthrough Designation likely
posted this to the other Board
//
Approval After Phase I: Ceritinib Runs the Three-Minute Mile
Oncologist. 2014 Jun; 19(6): 577–578.
Published online 2014 May 1. doi: 10.1634/theoncologist.2014-0143
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4041677/
EXCERPT
Thirteen years ago, I wrote an editorial applauding discovery, development, and marketing approval of imatinib for chronic myelogenous leukemia (CML), a signal event in the history of targeted therapy, and the oncology equivalent of the four-minute mile [1]. It took 3 years from the start of trials and required the confirmatory evidence of two phase II studies to receive the U.S. Food and Drug Administration’s (FDA) stamp of conditional approval. A decade later, these pages called attention to the rapid 3-year development of crizotinib for ALK-translocated non-small cell lung cancer (NSCLC), again based on a highly positive phase I and a confirmatory phase II [2]. In that editorial, I predicted that, someday soon, the FDA would approve a new targeted agent after phase I. That day has come to pass with the approval of ceritinib for ALK-rearranged NSCLC.
The strategy for targeted drug development is now radically different from the equivalent trials of cytotoxic drugs. In the case of ceritinib, the research team knew the drug’s target, were able to select the patients that have tumors expressing the target, and could quickly expand the phase I study to include large numbers of patients, thereby accumulating convincing data on efficacy and safety in phase I. The old saw that phase I is all about safety and phase II is all about efficacy no longer applies. Phase I is all about Proof of Principle and efficacy, once a safe dose is reached. [sounds familiar]
Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper
http://www.forbes.com/sites/aroy/2012/05/04/s...ew-herper/
https://youtu.be/V8x446Yd7_Y
to my mind, the above means Kevetrin is setting up well... how "convincing" the data coming out of K's Ph I in adv of the planned Ph IIs---now that is the Q... hints, but more proof obv needed. if it adds months in PFS, Breakthrough Designation likely
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