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Posted On: 05/30/2017 1:08:27 PM
Post# of 72446
Re: someconcerns #34320
Precipitated by one of scotty's statements, SLC had some good stuff on how some drugs get approved after Ph11:
Quote:
slcimmuno Member Level Tuesday, 05/30/17 07:35:44 AM
Re: scottsmith post# 183577
Post # of 183651
And successful P2s, particularly in oncology, can sometimes be sufficient evidence toward gaining expedited approval -- not saying we're there yet, of course, but w push to Prec Med, farrel90 post, Kevetrin one day may be well-positioned for fast approval/s across the many cancers affected by p53 if results pan out.
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"Approval of New Agents after Phase II Trials."
Abstract
Cancer drug approval has evolved as the understanding of cancer biology, and the ability to select patients for trials of targeted agents, has matured. The longstanding reliance on Phase III trials to prove drug efficacy and positive impact on patient survival may no longer be necessary, as early trials, particularly the expansion phase of a Phase I trial, may provide convincing evidence of a high response rate to a targeted drug in a patient population who has been poorly responsive to conventional therapy. If the new drug produces no safety signals of great concern, and if a validated biomarker for patient selection has been established and is readily available, accelerated approval may be achievable prior to completion of a randomized trial. The advantages, and potential downside, of rapid approval scenarios will be discussed in this article.
https://www.ncbi.nlm.nih.gov/m/pubmed/24451821/
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"Approval After Phase I: Ceritinib Runs the Three-Minute Mile"
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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4041677/
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