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Oncopeptides submits application for conditional marketing authorization of melflufen in the EU

Marty Duvall

Oncopeptides has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the 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.

“Following Oncopeptides´ launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations”, says Marty J Duvall, Chief Executive Officer at Oncopeptides. “This major milestone marks the commitment of our organization to bring hope to multiple myeloma patients around the world, through innovative science”.

Photo of Marty Duvall: Oncopeptides