CHMP rejects Folotyn (AllosTherapeutics and Mundipharma) for T-Cell Lymphoma - 25-Jan-2012

The CHMP adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Folotyn,(pralatrexate injection), from Allos Therapeutics, intended for the treatment of peripheral T-cell Lymphoma. The CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not compared with any other treatment or placebo in another group of patients. Moreover, there was no clear improvement seen in the condition of the patients, as the study looked at the patients’ response to treatment but did not further allow the Committee to assess the effect on overall survival. The drug has Accelerated Approval in the USA. MundiPharma have the European rights.