The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion, recommending the refusal of the marketing authorisation for pralatrexate (Folotyn), intended for the treatment of peripheral T-cell lymphoma.

The Committee was concerned that the main study was designed in a way that did not allow the assessment of benefit, particularly since the drug was not compared with any other treatment or placebo. Moreover, the study only assessed response to treatment so impact on progression free- or overall-survival is not known. Therefore the Committee concluded that the medicine’s benefits did not outweigh its risks.