Posted by Michael Wonder on 28 Jun 2020
ERC Belgium submits marketing authorisation application to European Medicines Agency for glioblastoma immunotherapy, Sitoiganap
26 June 2020 - ERC Belgium has announced that it has submitted to the EMA its marketing authorisation application for conditional approval of its lead product Sitoiganap (ERC1671) to treat recurrent glioblastoma.
The application contains observations suggesting safety and efficacy of Sitoiganap demonstrated from the interim data of a randomised double-blind phase II trial.
The data show that administration of Sitoganap/GM-CSF/cyclophosphamide combined with bevacizumab results in a clinically meaningful survival benefit with minimal toxicity.
