Three concerns derail Biovest's cancer vaccine approval hopes
This article was originally published in Scrip
Executive Summary
Biovest's investigational personalized cancer vaccine Lympreva, formerly known as BiovaxID (dasiprotimut-T), has been given a negative opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The committee, which examines marketing authorization applications before handing over its opinion for the European Commission to make a final decision, said that the principal study's design and execution was "inadequate [...] to establish the medicine's benefit".