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 Thursday the approval by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the use of DARZALEX (daratumumab), in combination with bortezomib, melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech Inc an exclusive worldwide licence to develop, manufacture and commercialise the product.

Reportedly, Genmab will receive a USD7m milestone payment from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label.

This approval and related milestone do not impact the financial guidance issued by the company on 14 August 2019, Genmab clarified.

The Ministry's approval is based on data from the phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50% in newly diagnosed ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Haematology (ASH) Annual Meeting and published in the New England Journal of Medicine in December 2017.

DARZALEX is the first monoclonal antibody (mAb) to receive US Food and Drug Administration (FDA) approval to treat multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the US.

Also, DARZALEX is the first human CD38 monoclonal antibody to reach the market in the US, Europe and Japan.