Missing comparator prompts CHMP no for Celgene's Istodax
This article was originally published in Scrip
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.
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