The European Medicines Agency (EMA) has adopted the International Conference on Harmonisation’s (ICH) questions and answers (Q&As) guideline on the non-clinical evaluation of anticancer drugs.
The guidance document contains 41 questions and answers offering additional clarity on ICH S9, including information on studies to support non-clinical evaluations such as toxicology studies and non-clinical data to support trial design and marketing. The document aims to address challenges that both regulators and the industry have experienced when interpreting and implementing the guideline since its adoption in 2009.
The Committee for Medicinal Products for Human Use (CHMP) adopted the ICH S9 guideline on non-clinical evaluation for anticancer Pharmaceuticals Q&A document soon after its adoption by the ICH assembly. The EMA expects the Q&A document will take effect on 16th November 2018.
The Q&A addresses issues including whether additional toxicology studies in animals are required for drugs that are shown to increase survival in patients (ICH states these are not usually warranted, however may be needed on a case-by-case basis), and what types of studies are necessary to support the clinical evaluation of drug combinations.
To view the ICH Q&A on non-clinical evaluation for cancer drugs, please click here.