Posted by Michael Wonder on 17 Apr 2021
Oncopeptides submits application for conditional marketing authorisation of melflufen in the EU
16 April 2021 - Oncopeptides today announces that the Company has submitted an application to the EMA for conditional marketing authorisation of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma.
Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.
