Posted by Michael Wonder on 29 Jun 2020
Daiichi Sankyo provides update on CHMP review of pexidartinib, a CSF1R inhibitor for the treatment of patients with TGCT
26 June 2020 - Daiichi Sankyo today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on the marketing authorisation application for pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumour.
The European marketing authorisation application was based on results of the pivotal phase 3 ENLIVEN study, which were published in The Lancet on 19 June 2019.
