EMA RELEASES NEW GUIDANCE ON ASSESSING ANTI-CANCER MEDICINES
January 1st, 2013 THE EUROPEAN Medicines Agency (EMA) has released new guidance for pharmaceutical companies on evaluating anti-cancer medicines. Its new advice, for instance, includes detail on confirmatory trials saying they should show how medicines can both destroy or halt the growth of cancers. More detailed guidance is included on using “cancer progression-free survival” in confirmatory trials and specific advice on treating non-small-cell lung cancer, prostate cancer, chronic myeloid leukaemia, and myelodysplastic syndromes, as well as haematopoietic stem cell ...
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