Lympreva dasiprotimut-T regulatory update

EMA’s CHMP recommended against approval of Lympreva dasiprotimut-T from Biovest to treat follicular non-Hodgkin’s lymphoma (NHL). CHMP said the Phase III trial of Lympreva was inadequately designed and carried out to establish the product’s benefit and its effectiveness following induction treatment with the current standard of care (SOC) had not been demonstrated. The agency also had concerns regarding the manufacture and quality control of Lympreva. ...