Missing comparator prompts CHMP no for Celgene's Istodax
This article was originally published in Scrip
Executive Summary
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion for Celgene's histone deacetylase inhibitor Istodax (romidepsin) in the treatment of peripheral T-cell lymphoma (PTCL), following failure of or recurrence after at least two prior therapies. It recognised that the product showed anti-tumour activity but said the study design did not enable it to reach a conclusion about the drug's clinical benefit because it was not compared with any other treatment.