Research & Development
Genmab reports grant of European Marketing Authorisation for DARZALEX in frontline multiple myeloma
21 January 2020 -

Genmab A/S (CPH: GMAB), a biotechnology company specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer, announced on Monday the grant by the European Commission (EC) of marketing authorisation for DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma, who are eligible for autologous stem cell transplant (ASCT).

This EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in December 2019. In August 2012, Genmab had granted Janssen Biotech Inc (Janssen) an exclusive worldwide license to develop, manufacture and commercialise daratumumab.

Reportedly, this approval was based on the phase III CASSIOPEIA (MMY3006) study sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Haematology Oncology (HOVON) and Janssen R&D LLC. Data from this study was published in The Lancet and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.