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ICH Advances Q&A on the Nonclinical Evaluation of Cancer Drugs

Posted 30 April 2018 | By Zachary Brennan 

ICH Advances Q&A on the Nonclinical Evaluation of Cancer Drugs

Following issues by both regulators and industry in interpreting and implementing the International Council for Harmonisation’s (ICH) S9 guideline on the nonclinical evaluation of cancer drugs, ICH has recently adopted a question and answer document to help.

The 19-page document includes more than 40 questions and answers, offering more clarity on the scope of the guideline, studies to support nonclinical evaluations such as toxicology studies, non-clinical data to support trial design and marketing, and other considerations.

Questions in the document include: “Are clinical trials in the adjuvant or neo-adjuvant setting covered under ICH S9?” (Yes) and “In the case where a therapeutic increases survival, what further toxicology work is recommended, and what is the appropriate timing of any studies?” (ICH says: “When the anticancer pharmaceutical is shown to extend survival of patients, no additional general toxicology studies are usually warranted.”).

The document also offers clarity situations where one species may be acceptable for toxicology testing.


The ICH S9 Guideline: “Nonclinical Evaluation for Anticancer Pharmaceuticals” reached Step 4 in November 2009, though since then, “all the parties using the guideline have experienced some challenges around implementation,” ICH said.

“Implementation of the guideline has revealed areas that are open to broad and divergent interpretation by both regulatory authorities and industry,” the Swiss group added.

For this reason, ICH formed an Implementation Working Group (IWG) in October 2014 to develop this Q&A document to provide additional clarity around cancer drug development.

“The Questions and Answers developed by the IWG are intended to facilitate the implementation of the S9 Guideline and, of additional benefit, to continue progress in the 3Rs of Reduction, Refinement, and Replacement in use of animals,” ICH said.

S9 Implementation Working Group ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers Current Step 4 version 27 April 2018


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