Biotechnology company Genmab A/S (CPH:GEN) announced on Tuesday the submission by Janssen Pharmaceutica NV (Janssen) of a Type II variation application to the European Medicines Agency (EMA).

Genmab said this application seeks to broaden the existing marketing authorisation for daratumumab (DARZALEX) to include use in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

This submission of the application triggers milestone payments totalling USD3.0m to Genmab from Janssen. These milestone payments were included in Genmab's financial guidance for 2017.

According to the company, this submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. This data will also be used as the basis for a potential regulatory submission to the US Food and Drug Administration.

Daratumumab is being developed by Janssen Biotech Inc under an exclusive worldwide license, granted in August 2012 by Genmab, to develop, manufacture and commercialise daratumumab from Genmab. Daratumumab has received two Breakthrough Therapy Designations from the US FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

Genmab specialises in the creation and development of differentiated antibody therapeutics for the treatment of cancer. It has two approved antibodies, DARZALEX (daratumumab), for the treatment of certain multiple myeloma indications, and Arzerra (ofatumumab), for the treatment of certain chronic lymphocytic leukaemia indications.