newsFDA priority review for AbbVie lymphoma bispecific antibody22 November 2022 | By Catherine Eckford (European Pharmaceutical Review)The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
newsEMA validates AbbVie lymphoma bispecific antibody application31 October 2022 | By Catherine Eckford (European Pharmaceutical Review)AbbVie's marketing application for epcoritamab in adults with relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
newsPhase II Lymphoma study of Daratumumab will not continue to stage 24 April 2017 | By Niamh Marriott, Junior EditorJanssen Biotech has decided not to initiate stage 2 of the Phase II study of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma...
newsGenmab to trial daratumumab in combination with carfilzomib to treat multiple myeloma17 November 2016 | By Niamh Louise Marriott, Digital Content ProducerGenmab’s daratumumab (darazalex) will be investigated in a Phase III clinical study in combination with carfilzomib (kyprolis) and dexamethasone...
newsFDA grants priority review for Genmabs’ daratumumab to treat relapsed multiple myeloma12 October 2016 | By Niamh Louise Marriott, Digital Content ProducerThe FDA has assigned a prescription drug user fee act (PDUFA) target date of February 17, 2017 to take a decision on daratumumab in this indication...
newsFDA approves Genmab’s ofatumumab for relapsed CLL31 August 2016 | By Niamh Louise Marriott, Digital Content ProducerApproval is supported by the Phase III complement study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL...
newsGenmab enters commercial DuoBody Technology agreement with BioNovion in the field of immuno-oncology20 February 2015 | By GenmabGenmab A/S has entered a co-development and commercialisation agreement with BioNovion to evaluate a number of DuoBody product candidates targeting immune checkpoints...
newsGenmab announces preliminary results in Phase II study of Daratumumab in double refractory multiple myeloma4 February 2015 | By GenmabGenmab A/S today announced preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma conducted by its collaboration partner Janssen Biotech...
newsGenmab announces new phase III combination study of Daratumumab in frontline multiple myeloma10 November 2014 | By Genmab A/SGenmab A/S announced today that the French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Biotech, Inc. plans to start an additional Phase III study of daratumumab in frontline multiple myeloma...
newsRegulatory update – GSK and Genmab announce European submission to regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)4 October 2013 | By GlaxoSmithKlineGlaxoSmithKline plc and Genmab announced the submission of a variation to the Marketing Authorisation to the European Medicines Agency (EMA) for the use of Arzerra...
