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 Tuesday the grant by the European Commission (EC) of marketing authorisation for DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd), as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible 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 October 2019. In August 2012, Genmab had granted Janssen Biotech Inc (Janssen) an exclusive worldwide license to develop, manufacture and commercialise daratumumab.

The company added that this approval was based on data from the phase III MAIA (MMY3008) study of daratumumab in combination with Rd as treatment for patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT. Data from this study was published in 'The New England Journal of Medicine' and was presented as a Late-Breaking Abstract at the 2018 American Society of Haematology (ASH) Annual Meeting in December 2018.